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Childrens Pain and Fever Acetaminophen 160 mg/5mL Suspension — NDC 58602-0165-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Childrens Pain and Fever Acetaminophen 160 mg/5mL Suspension — NDC 58602-165-20 (Billing 58602-0165-20) · Product 58602-165

by Aurohealth LLC · 1 BOTTLE in 1 CARTON (58602-165-20) / 236 mL in 1 BOTTLE

NDC 58602-165-20 (billing 58602-0165-20) is a package of Childrens Pain and Fever Acetaminophen 160 mg/5mL Suspension from Aurohealth LLC, marketed since Jul 2026 and currently FDA-listed. It is the main listing for product NDC 58602-165, which comes in 2 package sizes.

NDC 58602-0165-20
🏷️ FDA NDC (as labeled) 58602-165-20 billing pads the product segment with a zero
This package
Contains236 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 58602-165 · Also comes in: 118 mL 58602-165-24
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-165-20
Product NDC 58602-165
11-digit billing NDC 58602016520
RxCUI 307668
UNII 362O9ITL9D
Application # M013
SPL Set ID e4a2566e-48ec-4602-87e3-143398d15f33
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-23
Route ORAL
Dosage form SUSPENSION
Substance ACETAMINOPHEN
Quick answers for NDC 58602-165-20
  • RxCUI (RxNorm): 307668
  • 11-digit billing NDC: 58602016520
Why two NDCs? The FDA registers this code as 58602-165-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58602-0165-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 118 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58602-0165-20 58602-165-20 You're viewing this Main listing 1 BOTTLE in 1 CARTON (58602-165-20) / 236 mL in 1 BOTTLE 2026-07-23 — Active
58602-0165-24 58602-165-24 1 BOTTLE in 1 CARTON (58602-165-24) / 118 mL in 1 BOTTLE 2026-07-23 — Active

Pack size FAQ

What quantity is in NDC 58602-0165-20?
NDC 58602-0165-20 is listed by the FDA — 1 bottle in 1 carton / 236 ml in 1 bottle.
What NDC number is used to bill for this package of Childrens Pain and Fever Acetaminophen 160 mg/5mL Suspension?
Bill NDC 58602-0165-20 — the 11-digit billing format is 58602016520. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pain Reliever Childrens 160 mg/5mL 62011-0460-01 Strategic 1 bottle $0.019 — Discontinued —
leader childrens pain and fever 160 mg/5mL 70000-0496-01 Cardinal 1 bottle $0.019 — FDA listed —
Pain and Fever Childrens 160 mg/5mL 62011-0461-01 Strategic 1 bottle $0.019 — Discontinued —
Pain Relief Childrens 160 mg/5mL 63868-0175-26 QUALITY 1 bottle $0.021 — FDA listed —
Childrens Pain Relief 160 mg/5mL 63868-0174-18 QUALITY 118 ml $0.021 — Discontinued —
Childrens Acetaminophen 160 mg/5mL 72888-0459-01 Advagen 1 bottle $0.021 — Availability likely —
Good Neighbor Pharmacy Childrens Pain and Fever 160 mg/5mL 46122-0209-26 Amerisource 1 bottle $0.021 — Availability likely —
good sense childrens pain and fever 160 mg/5mL 00113-0608-26 L. 1 bottle $0.021 — Availability likely —
Pain Reliever 160 mg/5mL 83324-0161-04 QUALITY 1 bottle $0.021 — Availability likely —
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mL 83474-0001-04 Puro 1 bottle $0.021 — Availability likely —
good sense childrens pain and fever 160 mg/5mL 00113-0020-26 L. 1 bottle $0.021 — Availability likely —
Good Sense Pain and Fever 160 mg/5mL 00113-8959-26 L. 1 bottle $0.021 — Availability likely —
Good Neighbor Pharmacy childrens pain and fever 160 mg/5mL 46122-0211-26 Amerisource 1 bottle $0.021 — Availability likely —
good neighbor pharmacy pain and fever childrens 160 mg/5mL 46122-0322-26 Amerisource 1 bottle $0.021 — Availability likely —
Rugby Childrens Acetaminophen 160 mg/5mL 00536-1321-97 Rugby 1 bottle $0.021 — Availability likely —
Good Sense Childrens Pain and Fever 160 mg/5mL 00113-0212-26 L. 1 bottle $0.021 — Availability likely —
foster and thrive childrens pain and fever 160 mg/5mL 70677-1143-01 Strategic 1 bottle $0.021 — Availability likely —
Childrens Acetaminophen 160 mg/5mL 45802-0201-26 Padagis 1 bottle $0.021 — Availability likely —
foster and thrive childrens pain and fever 160 mg/5mL 70677-1142-01 Strategic 1 bottle $0.021 — Availability likely —
childrens acetaminophen 160 mg/5mL 00904-7445-20 Major 1 bottle $0.021 — Availability likely —
leader childrens pain and fever 160 mg/5mL 70000-0028-01 Cardinal 1 bottle $0.021 — Availability likely —
Pain Relief 160 mg/5mL 83324-0034-04 QUALITY 1 bottle $0.021 — Availability likely —
leader childrens pain and fever 160 mg/5mL 70000-0481-01 Cardinal 1 bottle $0.021 — Availability likely —
good neighbor pharmacy infants pain and fever 160 mg/5mL 46122-0764-34 Amerisource 1 bottle $0.041 — Availability likely —
Good Neighbor Pharmacy Infants Pain and Fever 160 mg/5mL 46122-0765-34 Amerisource 1 bottle $0.041 — Availability likely —
foster and thrive infants pain and fever 160 mg/5mL 70677-1253-01 Strategic 1 bottle $0.041 — Availability likely —
rugby infants acetaminophen 160 mg/5mL 00536-1426-77 Rugby 1 bottle $0.058 — Availability likely —
leader infants pain and fever 160 mg/5mL 70000-0674-01 Cardinal 1 bottle $0.058 — Availability likely —
Infants Pain Reliever 160 mg/5mL 70677-0117-01 Strategic 1 bottle $0.062 — Discontinued —
good sense pain and fever infants 160 mg/5mL 00113-0946-10 L. 1 bottle $0.084 — Availability likely —
Good Sense pain and fever 160 mg/5mL 00113-0161-10 L. 1 bottle $0.084 — Availability likely —
Childrens Pain and Fever Cherry flavor 160 mg/5mL 00363-0322-24 Walgreen 1 bottle — — FDA listed —
Childrens Pain and Fever, Grape flavor 160 mg/5mL 00363-0323-24 Walgreen 1 bottle — — FDA listed —
Pain Relief Childrens 160 mg/5mL 55910-0282-08 Dolgencorp, 1 bottle — — FDA listed —
Good Sense Childrens Pain and Fever 160 mg/5mL 71205-0601-04 Proficient 1 bottle — — FDA listed —
Childrens Acetaminophen Dye Free Grape 160 mg/5mL 81522-0285-04 FSA 1 bottle — — FDA listed —
up and up acetaminophen infants 160 mg/5mL 11673-0133-16 Target 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 30142-0766-16 Kroger 1 bottle — — FDA listed —
equaline childrens acetaminophen 160 mg/5mL 41163-0473-26 United 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0766-16 Meijer 1 bottle — — FDA listed —
CareOne Infants Acetaminophen 160 mg/5mL 41520-0363-10 American 1 bottle — — Discontinued —
Childrens Pain And Fever 160 mg/5mL 42507-0148-26 HyVee 1 bottle — — FDA listed —
equate pain and fever infants 160 mg/5mL 49035-0946-10 Wal-Mart 1 bottle — — Discontinued —
Dye Free Pain Reliever Childrens 160 mg/5mL 49580-0685-04 P 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 51316-0643-04 CVS 1 bottle — — FDA listed —
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPE 160 mg/5mL 53942-0526-24 DeMoulas 1 bottle — — FDA listed —
childrens pain relief 160 mg/5mL 56062-0130-26 Publix 1 bottle — — FDA listed —
pain relief 160 mg/5mL 56062-0590-16 Publix 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 63868-0677-60 CHAIN 60 ml — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0231-61 Precision 10 cups — — FDA listed —
WalgreenChildrens Pain Fever 160 mg/5mL 00363-6950-04 WALGREENS 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 69729-0028-02 OPMX 60 ml — — FDA listed —
basic care childrens pain and fever 160 mg/5mL 72288-0175-26 Amazon.com 1 bottle — — FDA listed —
Dye Free Pain Reliever Childrens 160 mg/5mL 21130-0285-04 Safeway, 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0590-16 Topco 1 bottle — — FDA listed —
Dye Free Childrens Acetaminophen 160 mg/5mL 00121-0966-00 PAI 10 cups — — FDA listed —
Panadol 160 mg/5mL 00135-0539-02 Haleon 1 bottle — — FDA listed —
Childrens Pain and Fever Dye Free 160 mg/5mL 41226-0779-05 KROGER 1 bottle — — FDA listed —
careone childrens acetaminophen 160 mg/5mL 41520-0624-26 American 1 bottle — — FDA listed —
CareOne Infants Acetaminophen 160 mg/5mL 41520-0709-10 American 1 bottle — — FDA listed —
Pain and Fever Childrens 160 mg/5mL 49580-0282-02 P 118 ml — — FDA listed —
Pain Reliever 160 mg/5mL 49580-2880-04 P 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0325-01 Kenvue 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0099-19 CVS 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 55319-0559-04 Family 1 bottle — — FDA listed —
Dolex Children Pain and Fever 160 mg/5mL 55758-0026-04 Pharmadel 1 bottle — — FDA listed —
INFANTS Pain and Fever 160 mg/5mL 58602-0172-11 Aurohealth 1 bottle — — FDA listed —
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0285-04 Walgreens 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0038-58 Precision 10 syringes — — FDA listed —
Childrens Pain Reliever 160 mg/5mL 68391-0288-12 BJWC 3 bottles — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0100-09 Genexa 1 bottle — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0121-09 Genexa 1 bottle — — FDA listed —
Temp X 160 mg/5mL 69729-0047-02 OPMX 60 ml — — FDA listed —
Neo-Lubrina 160 mg/5mL 69729-0118-04 OPMX 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 71335-2722-01 Bryant 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0946-16 Amazon.com 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0595-04 Rite 1 bottle — — FDA listed —
topcare childrens pain and fever 160 mg/5mL 36800-0202-26 Topco 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 00121-1781-00 PAI 10 cups — — FDA listed —
childrens pain and fever 160 mg/5mL 42507-0804-26 HyVee 1 bottle — — FDA listed —
equate childrens pain and fever 160 mg/5mL 49035-0959-26 Wal-Mart 1 bottle — — Discontinued —
Childrens TYLENOL 160 mg/5mL 50580-0579-02 Kenvue 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0282-04 CVS 1 bottle — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 68071-3869-04 NuCare 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 00363-8079-36 Walgreen 1 bottle — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0042-09 Genexa 1 bottle — — FDA listed —
Infants Pain and Fever Cherry Flavor 160 mg/5mL 69676-0097-09 Genexa 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 70677-1286-01 Strategic 473 ml — — FDA listed —
Pain Reliever 160 mg/5mL 79903-0172-04 WALMART 1 bottle — — FDA listed —
Up and Up childrens acetaminophen 160 mg/5mL 11673-0105-26 Target 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0959-01 Rite 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 30142-0818-26 Kroger 1 bottle — — FDA listed —
Panadol 160 mg/5mL 00135-0537-01 Haleon 1 bottle — — FDA listed —
good neighbor pharmacy childrens pain and fever 160 mg/5mL 46122-0210-25 Amerisource 1 bottle — — Discontinued —
Equate Childrens Pain and Fever 160 mg/5mL 49035-0313-26 Wal-Mart 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0424-01 Kenvue 1 bottle — — FDA listed —
Pediacare Childrens Grape 160 mg/5mL 52412-0901-04 RANDOB 1 bottle — — FDA listed —
Llorens Care Children Acetaminophen 160 mg/5mL 54859-0850-04 Llorens 118 ml — — FDA listed —
dg health childrens pain and fever 160 mg/5mL 55910-0010-26 Dolgencorp 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 63941-0282-04 Best 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 68071-4860-04 NuCare 118 ml — — FDA listed —
Dye Free Childrens Acetaminophen 160 mg/5mL 68094-0061-61 Precision 10 cups — — FDA listed —
ADWE Childrens Pain Fever 160 mg/5mL 68163-0695-04 RARITAN 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 68788-8397-01 Preferred 1 bottle — — FDA listed —
Temperal-ito 160 mg/5mL 69729-0006-02 OPMX 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 82673-0104-04 KinderFarms, 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0107-01 Rite 1 bottle — — FDA listed —
infants fever reducer and pain reliever 160 mg/5mL 11822-0590-01 Rite 1 bottle — — FDA listed —
signature care infants pain relief 160 mg/5mL 21130-0178-16 Safeway 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0554-26 Meijer 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0590-16 Meijer 1 bottle — — FDA listed —
Parents Choice Infants Pain and Fever 160 mg/5mL 49035-0766-16 Wal-Mart 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0170-01 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0599-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0614-01 Kenvue 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0098-19 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0324-04 CVS 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 58602-0173-11 Aurohealth 1 bottle — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 68788-8477-01 Preferred 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-6555-04 WALGREENS 1 bottle — — FDA listed —
Walgreen Childrens Pain plus Fever 160 mg/5mL 00363-6958-08 WALGREENS 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 00363-7015-04 WALGREENS 1 bottle — — FDA listed —
Genexa Kids Pain and Fever 160 mg/5mL 69676-0099-09 Genexa 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 71205-0263-04 Proficient 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0766-16 Amazon.com 1 bottle — — FDA listed —
Pain Relief Fever Reducer children 160 mg/5mL 80272-0002-04 Ellywell, 1 bottle — — FDA listed —
Pain and Fever Childrens 160 mg/5mL 82673-0097-04 KinderFarms, 1 bottle — — FDA listed —
OneSsip Acetaminophen 160 mg/5mL 87078-0131-52 MEDWISE 12 pouches — — FDA listed —
Up and Up Childrens acetaminophen 160 mg/5mL 11673-0130-26 Target 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0766-16 Topco 1 bottle — — FDA listed —
Pain and Fever 160 mg/5mL 37808-0161-16 H 1 bottle — — FDA listed —
Pain Relief Childrens Dye Free 160 mg/5mL 37808-0285-04 H 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0946-10 Meijer 1 bottle — — Discontinued —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0615-26 American 1 bottle — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 50090-7254-00 A-S 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0433-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0612-01 Kenvue 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0097-19 CVS 1 bottle — — FDA listed —
Childrens Pain plus Fever Relief 160 mg/5mL 51316-0569-04 CVS 1 bottle — — FDA listed —
CVS Childrens Pain plus Fever Relief 160 mg/5mL 51316-0695-04 CVS 1 bottle — — FDA listed —
FeverAll 160 mg/5mL 51672-5319-08 Sun 1 bottle — — FDA listed —
infants pain fever 160 mg/5mL 59640-0590-16 H 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 63868-0678-60 CHAIN 60 ml — — FDA listed —
childrens pain and fever 160 mg/5mL 00363-0212-26 Walgreen 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0042-58 Precision 10 syringes — — FDA listed —
Dye FreeInfants Pain and Fever 160 mg/5mL 00363-6020-02 WALGREEN 1 bottle — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0105-26 Amazon.com 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0590-16 Amazon.com 1 bottle — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0959-26 Amazon.com 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 30142-0590-16 Kroger 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0946-10 Topco 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 00121-0941-00 PAI 10 cups — — FDA listed —
pain relief 160 mg/5mL 37808-0130-26 H 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 41226-0910-04 Kroger 1 bottle — — FDA listed —
childrens pain and fever 160 mg/5mL 41250-0959-26 Meijer 1 bottle — — FDA listed —
equate pain and fever childrens 160 mg/5mL 49035-0042-26 Wal-Mart 1 bottle — — FDA listed —
TYLENOL For Children Plus Adults 160 mg/5mL 50580-0177-08 Kenvue 1 bottle — — FDA listed —
Infants Pain Relief 160 mg/5mL 56062-0766-16 Publix 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-6002-02 WALGREEN 1 bottle — — FDA listed —
Mejoralito 160 mg/5mL 69729-0068-02 OPMX 60 ml — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 72162-2279-02 Bryant 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76281-0526-24 AptaPharma 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 85828-0922-05 Grocery 1 bottle — — FDA listed —
Topcare pain and fever 160 mg/5mL 36800-0161-10 Topco 1 bottle — — FDA listed —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0023-26 American 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 51316-0606-16 CVS 1 bottle — — FDA listed —
Fast Acting Pedia Crae 160 mg/5mL 52412-0912-01 Randob 1 bottle — — FDA listed —
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRY 160 mg/5mL 53942-0525-24 DeMoulas 1 bottle — — FDA listed —
Childrens Pain Relief 160 mg/5mL 55319-0060-36 Family 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 55319-0206-02 FAMILY 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 55319-0558-08 Family 1 bottle — — FDA listed —
INFANTS Pain and Fever 160 mg/5mL 58602-0168-11 Aurohealth 1 bottle — — FDA listed —
infants pain fever 160 mg/5mL 59640-0766-16 H 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 59779-0308-26 CVS 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 59779-0590-16 CVS 1 bottle — — FDA listed —
Childrens Acetaminophen Oral Suspension 160 mg/5mL 60687-0762-17 American 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0330-61 Precision 10 cups — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-1630-94 Walgreen 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 00363-7014-05 WALGREENS 1 bottle — — FDA listed —
Careone Infants Acetaminophen 160 mg/5mL 72476-0766-16 Retail 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76162-0079-36 TOPCO 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76281-0525-24 AptaPharma 1 bottle — — FDA listed —
KOSHER MEDS Childrens Pain and Fever 160 mg/5mL 82179-0002-04 Mollec 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 82673-0098-02 KinderFarms, 1 bottle — — FDA listed —
up and up infants acetaminophen 160 mg/5mL 11673-0266-16 Target 1 bottle — — FDA listed —
infants fever reducer and pain reliever 160 mg/5mL 11822-0766-01 Rite 1 bottle — — FDA listed —
Childrens Pain Relief 160 mg/5mL 37808-0482-04 H 1 bottle — — FDA listed —
Pain and Fever 160 mg/5mL 41250-0161-16 Meijer 1 bottle — — FDA listed —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0800-26 American 1 bottle — — FDA listed —
Pain Relief 160 mg/5mL 49580-0821-04 P 1 bottle — — FDA listed —
Childrens Tylenol 160 mg/5mL 50580-0139-04 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0154-02 Kenvue 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 55154-5787-05 Cardinal 5 cups — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 59779-0126-26 CVS 1 bottle — — FDA listed —
Pain and Fever Childrens 160 mg/5mL 59779-0785-08 CVS 1 bottle — — FDA listed —
Lil Drug Store Childrens Pain and Fever 160 mg/5mL 66715-6956-04 Lil' 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0030-62 Precision 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0130-58 Precision 10 syringes — — FDA listed —
childrens pain and fever 160 mg/5mL 00363-1239-26 Walgreen 1 bottle — — FDA listed —
childrens pain and fever 160 mg/5mL 69842-0959-26 CVS 1 bottle — — FDA listed —
equate infants pain and fever 160 mg/5mL 79903-0225-02 WALMART 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 82673-0096-02 KinderFarms, 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 00904-7278-70 Major 10 cups — — FDA listed —
signature care childrens pain relief 160 mg/5mL 21130-0243-26 Safeway 1 bottle — — FDA listed —
better living brands childrens fever and pain reliver 160 mg/5mL 21130-0746-04 BETTER 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0631-26 Meijer 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0650-26 Meijer 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0509-01 Kenvue 1 bottle — — FDA listed —
Pediacare Childrens Acetaminophen Grape 160 mg/5mL 52412-0906-01 RANDOB 1 bottle — — FDA listed —
Family Wellness Childrens Pain Reliever 574 160 mg/5mL 55319-0930-03 Family 1 bottle — — FDA listed —
DG Health Childrens Pain and Fever 160 mg/5mL 55910-0251-26 Dolgencorp, 1 bottle — — FDA listed —
dg health childrens pain and fever 160 mg/5mL 55910-0738-26 Dolgencorp 1 bottle — — FDA listed —
infants pain relief 160 mg/5mL 56062-0946-10 Publix 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 58602-0169-11 Aurohealth 1 bottle — — FDA listed —
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0283-04 Walgreens 1 bottle — — FDA listed —
Good Sense Childrens Pain and Fever 160 mg/5mL 68788-8407-01 Preferred 1 bottle — — FDA listed —
Good Sense Pain and Fever 160 mg/5mL 68788-8646-01 Preferred 1 bottle — — FDA listed —
Mommys Bliss Childrens Pain and Fever 160 mg/5mL 71444-0793-01 Mom 118 ml — — FDA listed —
Mommys Bliss Infants Pain and Fever 160 mg/5mL 71444-0893-01 Mom 59 ml — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0130-26 Amazon.com 1 bottle — — FDA listed —
Infants Pain And Fever 160 mg/5mL 72288-0157-16 Amazon.com 1 bottle — — FDA listed —
Good Sense Infants Pain And Fever 160 mg/5mL 00113-9523-16 L. 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mLthis 58602-0165-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0166-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0164-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0171-20 Aurohealth 1 bottle — — FDA listed —
KinderFarms Childrens Pain and Fever 160 mg/5mL 82673-0108-04 KinderFarms, 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0167-20 Aurohealth 1 bottle — — FDA listed —
KinderFarms Infants Pain and Fever 160 mg/5mL 82673-0100-02 KinderFarms, 1 bottle — — FDA listed —
Genexa Kids Pain and Fever 160 mg/5mL 69676-0101-09 Genexa 1 bottle — — FDA listed —
Childrens Pain And Fever 160 mg/5mL 72288-0702-34 Amazon.com 1 bottle — — FDA listed —
Pain Relief Childrens 160 mg/5mL 67091-0466-04 WinCo 1 bottle — — FDA listed —
Desenfriol-Ito Plus 160 mg/5mL 69729-0835-02 OPMX 1 bottle — — FDA listed —
Pentrexcilina 160 mg/5mL 69729-0824-02 OPMX 1 bottle — — FDA listed —
Mejoralito 160 mg/5mL 69729-0823-02 OPMX 1 bottle — — FDA listed —
Up And Up Childrens Acetaminophen 160 mg/5mL 82442-0151-34 Target 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Red
FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 9E0S3UM200
    A sugar alcohol solution derived from glucose that stays liquid without forming crystals. It functions as a sweetener, humectant (moisture-retaining agent), and solvent in liquid medications and syrups.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbutylparaben, carboxymethylcellulose sodium, citric acid anhydrous, FD & C red no. 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum. Questions or comments?  1-855-274-4122 Distributed by:  AUROHEALTH  LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAurohealth LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code58602
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

⏱️ Dosage and Administration 142 words ▾

Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours * or as directed by a doctor Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL Attention: use only enclosed dosing cup specifically designed for use with this product.

Do not use any other dosing device.

⚠️ Warnings 91 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen. Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

📦 Storage and Handling 13 words ▾

Other information each 5 mL contains: sodium 6 mg store at 20°-25°C (68°-77°F)

🧪 Active Ingredient 12 words ▾

Drug Facts Active ingredient (in each 5 mL) Acetaminophen, USP 160 mg

🧪 Inactive Ingredients 55 words ▾

Inactive ingredients butylparaben, carboxymethylcellulose sodium, citric acid anhydrous, FD & C red no. 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum. Questions or comments?

1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 43 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if your child has liver disease

📄 Ask a Doctor or Pharmacist Before Use If 17 words ▾

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

📄 When Using This Product 12 words ▾

When using this product do not exceed recommended dose (see overdose warning).

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Package Label / Principal Display Panel 142 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Container Label AUROHEALTH NDC 58602-165-24 AGES 2-11 YEARS Children's PAIN & FEVER Suspension Liquid Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever & Fever Reducer Alcohol, Aspirin, Ibuprofen & Gluten Free Cherry Flavor Use ONLY enclosed dosage cup 4 FL OZ (118 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Carton Label NDC 58602-165-24 ** Compare to Children's TYLENOL ® Oral Suspension active ingredient AUROHEALTH AGES 2-11 YEARS Children's PAIN & FEVER Suspension Liquid Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever & Fever Reducer Alcohol Free Aspirin Free Ibuprofen Free Gluten Free Cherry Flavor Use ONLY enclosed dosage cup 4 FL OZ (118 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58602-165-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58602-0165-20, written without dashes as 58602016520. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58602-0165-20, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0165) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (58602-0165-24). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurohealth LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 58602-0164-20 · Aurohealth 58602-0166-20 · Aurohealth →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.