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Diphenhydramine Hydrochloride 12.5 mg/5mL Solution, 118 mL — NDC 83720-0502-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diphenhydramine Hydrochloride 12.5 mg/5mL Solution, 118 mL — NDC 83720-502-04 (Billing 83720-0502-04)

by Oncor Pharmaceuticals · 118 mL in 1 BOTTLE

This is a package of 118 mL of Diphenhydramine Hydrochloride 12.5 mg/5mL Solution from Oncor Pharmaceuticals, marketed since Mar 2025 and currently FDA-listed.

NDC 83720-0502-04
🏷️ FDA NDC (as labeled) 83720-502-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Product page 83720-0502-16 Also comes in: 473 ml 83720-502-16
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83720-502-04
Product NDC 83720-502
11-digit billing NDC 83720050204
RxCUI 1049906
UNII TC2D6JAD40
UPC 0383720502048, 0383720502161
Application # M012
SPL Set ID 06ecba97-c790-4672-a8c3-f9caf6272d26
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-27
Route ORAL
Dosage form SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 41200030100920
GCN Seq No 016675
GCN 48831
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name DIPHENHYDRAMINE 12.5 MG/5 ML
FDB brand name Diphenhydramine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016675
  • GCN: 48831
  • GPI-14 (Medi-Span): 41200030100920
  • HICL (First Databank): 004480
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1049906
Why two NDCs? The FDA registers this code as 83720-502-04 — 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 → 83720-0502-04. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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

Label name DIPHENHYDRAMINE 12.5 MG/5 ML Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Oral products temporarily relieve hay fever and other upper respiratory allergy symptoms like runny nose, sneezing and itchy, watery eyes. They also ease runny nose and sneezing fr...
  • Oral forms are generally taken every 4 to 6 hours, with no more than 6 doses in 24 hours. The amount depends on age and the product, so check the package chart or ask me or your do...
  • It can. Drowsiness is common, so be careful driving or using machinery. Alcohol, sedatives and tranquilizers make it worse, so avoid them.
  • Oral products are not for children under 2 years, and some are not for children under 6. Children can become excitable, and overdose can be very dangerous. Always follow the age di...
📖 Read our full Diphenhydramine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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: 473 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 Per unit Per pack Marketing startMarketing endStatus
83720-0502-04 You're viewing this 118 mL in 1 BOTTLE — — 2025-03-27 — Active
83720-0502-16 83720-502-16 Main listing 473 mL in 1 BOTTLE $0.0174 / mL $8.25 2025-03-27 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle.
How does this package differ from NDC 83720-0502-16?
Both are Diphenhydramine Hydrochloride 12.5 mg/5mL Solution — the drug itself is identical. This page's package is the 118 mL one, while NDC 83720-0502-16 is the 473 ml package.
What NDC number is used to bill for this package of Diphenhydramine Hydrochloride 12.5 mg/5mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 12.5 mg/5mL 63868-0370-04 QUALITY 1 bottle $0.016 — FDA listed —
Childrens Allergy 12.5 mg/5mL 63868-0823-54 QUALITY 1 bottle $0.016 — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00904-6985-16 Major 473 ml $0.017 — Availability likely —
Allergy Relief Childrens 12.5 mg/5mL 00904-7533-15 Major 473 ml $0.017 — Availability likely —
Allergy Relief 12.5 mg/5mL 54859-0811-16 LLORENS 473 ml $0.017 — Availability likely —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 81033-0029-16 Kesin 473 ml $0.017 — Availability likely —
Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 CARDINAL 1 bottle $0.018 — Availability likely —
good sense allergy 12.5 mg/5mL 00113-0379-26 L. 1 bottle $0.019 — Availability likely —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 Amerisource 1 bottle $0.019 — Availability likely —
Allergy Relief 50 mg/20mL 46122-0685-26 Amerisource 1 bottle $0.019 — Availability likely —
Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 AMERISOURCE 1 bottle $0.019 — Availability likely —
Diphenhydramine Oral Liquid 12.5 mg/5mL 57237-0305-12 Rising 118 ml $0.019 — Availability likely —
M-Dryl 12.5 mg/5mL 58657-0528-04 Method 120 ml $0.019 — Availability likely —
leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 Cardinal 1 bottle $0.019 — Availability likely —
Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 Cardinal 1 bottle $0.019 — Availability likely —
foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 Strategic 1 bottle $0.019 — Availability likely —
Diphenhydramine Hcl 12.5 Mg Per 5 Ml 12.5 mg/5mL 82568-0016-04 AARNA 118 ml $0.019 — Availability likely —
Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 Strategic 1 bottle $0.020 — Availability likely —
Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 Chain 1 bottle $0.027 — FDA listed —
Diphenhydramine Hydrochloride 12.5 mg/5mL 00121-0489-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00121-0865-00 PAI 10 cups — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 00121-0978-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 25 mg/10mL 00121-1730-00 PAI 10 cups — — FDA listed —
Wal Dryl Childrens Allergy 12.5 mg/5mL 00363-0092-08 Walgreens 1 bottle — — FDA listed —
Dye Free Wal Dryl Allergy childrens 12.5 mg/5mL 00363-0293-04 Walgreens 1 bottle — — FDA listed —
childrens Allergy Dye Free Wal Dryl 12.5 mg/5mL 00363-0710-08 WALGREEN 1 bottle — — FDA listed —
childrens allergy relief 12.5 mg/5mL 00363-1236-26 Walgreen 1 bottle — — FDA listed —
Adult Allergy Relief Dye Free 25 mg/10mL 00363-7100-04 WALGREEN 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 00363-8018-36 Walgreen 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 00904-7323-70 Major 100 cups — — Discontinued —
Diphenhydramine HCl Oral Solution 25 mg/10mL 00904-7324-72 Major 100 cups — — Discontinued —
Diphenhydramine HCl 25 mg/10mL 00904-7559-72 Major 10 cups — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00904-7560-70 Major 10 cups — — FDA listed —
Children Allergy Relief Bubblegum flavor 12.5 mg/5mL 11673-0832-04 TARGET 1 bottle — — FDA listed —
childrens allergy relief dye-free 12.5 mg/5mL 11673-0918-36 Target 1 bottle — — Discontinued —
Childrens Allergy Relief 12.5 mg/5mL 11822-0379-00 Rite 1 bottle — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 11822-0918-01 Rite 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 21130-0025-04 Safeway, 118 ml — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 21130-0563-05 BETTER 1 bottle — — Discontinued —
Bactimicina Childrens Allergy 12.5 mg/5mL 24286-1565-04 DLC 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 30142-0404-26 Kroger 1 bottle — — FDA listed —
childrens allergy 12.5 mg/5mL 30142-0651-26 Kroger 1 bottle — — FDA listed —
Topcare childrens allergy 12.5 mg/5mL 36800-0379-26 Topco 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 37808-0012-08 H 1 bottle — — FDA listed —
Allergy 12.5 mg/5mL 37808-0379-26 H 1 bottle — — FDA listed —
equaline allergy 12.5 mg/5mL 41163-0379-26 United 1 bottle — — FDA listed —
KROGER Dye Free Childrens Allergy Relief 12.5 mg/5mL 41226-0710-08 KROGER 1 bottle — — FDA listed —
allergy childrens 12.5 mg/5mL 41250-0379-26 Meijer 1 bottle — — FDA listed —
Meijer Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 41250-0710-08 MEIJER 1 bottle — — FDA listed —
CareOne Childrens Allergy Relief 12.5 mg/5mL 41520-0632-26 American 1 bottle — — FDA listed —
allergy 12.5 mg/5mL 42507-0379-26 HyVee 1 bottle — — FDA listed —
equate allergy relief 12.5 mg/5mL 49035-0379-26 Wal-Mart 1 bottle — — FDA listed —
Dye Free Childrens Allergy Relief 12.5 mg/5mL 49035-0600-04 WAL-MART 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 49580-0292-02 P 118 ml — — FDA listed —
Childrens Dye Free Allergy 12.5 mg/5mL 49580-0293-04 P 1 bottle — — FDA listed —
children allergy relief dye free cherry 12.5 mg/5mL 50090-6163-00 A-S 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 50090-6541-00 A-S 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50090-7824-00 A-S 1 bottle — — FDA listed —
Childrens Benadryl ALLERGY 12.5 mg/5mL 50580-0534-04 Kenvue 1 bottle — — FDA listed —
Childrens Benadryl DYE-FREE ALLERGY 12.5 mg/5mL 50580-0535-01 Kenvue 1 bottle — — FDA listed —
BENADRYL Allergy 12.5 mg/5mL 50580-0573-04 Kenvue 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50844-0015-19 L.N.K. 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0150-19 CVS 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0180-19 CVS 1 bottle — — FDA listed —
CVS dye-free childrens allergy 12.5 mg/5mL 51316-0710-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53942-0505-24 DeMoulas 118 ml — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53943-0505-26 Discount 237 ml — — FDA listed —
Allergy Relief 12.5 mg/5mL 54859-0837-04 LLORENS 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 55319-0315-36 Family 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 55319-0918-36 Family 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 55910-0124-36 DOLGENCORP, 1 bottle — — FDA listed —
dg health allergy childrens 12.5 mg/5mL 55910-0379-26 Dolgencorp, 1 bottle — — FDA listed —
Allergy Childrens Allergy 12.5 mg/5mL 55910-0891-04 Dolgencorp, 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 56062-0379-26 Publix 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 57237-0317-51 Rising 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 57237-0318-11 Rising 100 cups — — FDA listed —
Geri Dryl 12.5 mg/5mL 57896-0980-16 GERI-CARE 473 ml — — FDA listed —
CVS Health Childrens Allergy Relief 12.5 mg/5mL 59779-0793-10 CVS 10 vials — — FDA listed —
allergy relief childrens 12.5 mg/5mL 59779-0874-26 CVS 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 60687-0829-86 American 10 cups — — FDA listed —
Diphenhydramine HCl 25 mg/10mL 60687-0830-08 American 10 cups — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1159-01 Bryant 120 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1160-01 Bryant 473 ml — — FDA listed —
Dye Free Allergy childrens 12.5 mg/5mL 63868-0128-04 QUALITY 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 63941-0292-04 Best 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 63941-0505-26 Best 1 bottle — — FDA listed —
Best Choice Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 63941-0710-04 BEST 1 bottle — — FDA listed —
Winco Foods Childrens Allergy Relief Dye Free 12.5 mg/5mL 67091-0354-18 WINCO 1 bottle — — FDA listed —
good sense allergy 12.5 mg/5mL 68071-3734-04 NuCare 1 bottle — — FDA listed —
ADWE dye-free childrens allergy 12.5 mg/5mL 68163-0710-08 RARITAN 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 68788-7994-01 Preferred 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 68788-8274-01 Preferred 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 68998-0505-24 Marc 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 69168-0471-59 Allegiant 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 69256-0292-08 Harris 1 bottle — — Discontinued —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 69339-0151-17 Natco 10 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 69339-0152-17 Natco 10 cups — — FDA listed —
Kids Allergy 12.5 mg/5mL 69676-0039-09 Genexa 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 69676-0074-09 Genexa 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0174-36 CVS 1 bottle — — Discontinued —
Childrens Allergy Relief 12.5 mg/5mL 69842-0719-19 CVS 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0798-36 CVS 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 71205-0259-04 Proficient 1 bottle — — FDA listed —
Max Allergy Kids 12.5 mg/5mL 71399-0023-04 Akron 118 ml — — FDA listed —
Diphenhydramine HCL STRAWBERRY FLAVOR 12.5 mg/5mL 71800-0058-19 Innovida 119 ml — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 71872-7242-01 Medical 1 cup — AA FDA listed —
M-Dryl 12.5 mg/5mL 72162-1674-02 Bryant 120 ml — — FDA listed —
basic care childrens allergy relief 12.5 mg/5mL 72288-0379-26 Amazon.com 1 bottle — — FDA listed —
Dr Kids Allergy Relief 12.5 mg/5mL 73282-2521-01 CalmCo 24 vials — — FDA listed —
Calmco Allergy Relief 25 mg/10mL 73282-2524-02 CalmCo 18 vials — — FDA listed —
Diphenhydramine Oral Solution 12.5 mg/5mL 73564-0814-16 Aldama 1 bottle — — Discontinued —
Childrens Allergy 12.5 mg/5mL 76281-0505-24 AptaPharma 118 ml — — FDA listed —
Allergy Relief childrens 12.5 mg/5mL 79903-0175-08 WALMART 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 79903-0368-04 WALMART 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 79903-0411-04 WALMART 1 bottle — — FDA listed —
Puregen Labs Allergy Relief 12.5 mg/5mL 80513-0201-16 Advanced 473 ml — — FDA listed —
Childrens Allergy Relief Dye Free Bubble Gum 12.5 mg/5mL 81522-0293-04 FSA 1 bottle — — Discontinued —
Kosher Meds Childrens Allergy Relief 12.5 mg/5mL 82179-0004-04 Mollec 1 bottle — — FDA listed —
Target Dye Free Childrens Allergy Relief 12.5 mg/5mL 82442-0710-08 Target 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 82673-0109-04 KinderFarms, 1 bottle — — FDA listed —
Nighttime Cold and Cough 12.5 mg/5mL 82673-0191-04 KinderFarms, 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 83324-0326-04 Chain 1 bottle — — FDA listed —
QUALITY CHOICE Childrens Allergy Relief DYE FREE 12.5 mg/5mL 83324-0339-04 QUALITY 1 bottle — — FDA listed —
Diphenhydramine Hydrochloride 12.5 mg/5mLthis 83720-0502-04 Oncor 118 ml — — FDA listed —
Geri Dryl 12.5 mg/5mL 83939-0007-01 VERITYRX, 5 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 83939-0008-01 VERITYRX, 5 ml — — FDA listed —
Revasol Childrens Allergy 12.5 mg/5mL 84379-0286-04 Rnv 118 ml — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 84415-0012-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 84415-0013-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 84447-0103-01 Belleview 200000 ml — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution 12.5 mg/5mL 87078-0411-52 MEDWISE 12 pouches — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 12.5 mg/5mL 87078-0421-52 MEDWISE 12 pouches — — FDA listed —
Diphenhydramine hydrochloride 12.5 mg/5mL 31722-0600-11 Camber 1 bottle — AA FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 71741-0511-04 Redmont 118 ml — AA 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.

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

The official label also statescitric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

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

LabelerOncor Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code83720
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio9 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 🤰 Pregnancy 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Uses - sneezing - runny nose - itchy, watery eyes - itching of the nose or throat - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

⏱️ Dosage and Administration 61 words ▾

Directions - take every 4 to 6 hours or as directed by a doctor - do not take more then directed - mL=milliliter - find right dose on chart below Children under 2 years Do not use Children 2 to 5 years Ask a doctor Children 6 to 11 years 1-2 teaspoonful Adults and children 12 years and over 2-4 teaspoonful

⚠️ Warnings 22 words ▾

Warnings Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin

🤰 Pregnancy 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

🆘 Overdosage 15 words ▾

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

📦 Storage and Handling 42 words ▾

Other information - each 1 tsp (5mL) contains: sodium 4 mg - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing. - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

🧪 Active Ingredient 12 words ▾

Active ingredients (in each 5 mL teaspoonful) Purpose Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

🎯 Purpose 122 words ▾

Principal Display Panel Oncor Pharmaceuticals NDC 83720-502-16 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT. 16 OZ. (473 ml) NDC 83720-502-04 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT.

4 OZ. (118 ml) Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev.

03/25

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you have - glaucoma - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 39 words ▾

When using this product - marked drowsiness may occur - avoid alcoholic drinks - alcohol, sedatives, and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 22 words ▾

Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

📄 Package Label / Principal Display Panel 6 words ▾

Diphenhydramine (16 oz) Diphenhydramine (4 oz)

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml83720-0502-16 50 Rx · $551
118 ml this page83720-0502-04 No Medicaid data
Drug total (last 4 qtrs): 50 Rx · 6,982 units · $551 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Oncor Pharmaceuticals. 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 473 ml (83720-0502-16). 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?
Oncor Pharmaceuticals 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.
← 83720-0500-04 · Oncor 83720-0503-16 · Oncor →
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.