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Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg; 325 mg; 10 mg Capsule, Liquid Filled

by SOFTGEL HEALTHCARE PRIVATE LIMITED · 4 BLISTER PACK in 1 CARTON (35916-0155-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 35916-0155-01
🏷️ FDA NDC (as labeled) 35916-0155-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

FDA NDC (as labeled) 35916-0155-1
Product NDC 35916-0155
11-digit billing NDC 35916015501
RxCUI 1086997
UNII 04JA59TNSJ, 362O9ITL9D, 9D2RTI9KYH
UPC 0335916015511
Application # M012
SPL Set ID 1f7a6375-ab66-9782-e063-6394a90a99f3
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-15
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 35916-0155-1 — a 5-4-1 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 package segment → 35916-0155-01. 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.

🏭 Manufacturer & labeler

LabelerSOFTGEL HEALTHCARE PRIVATE LIMITED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio23 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter liquid-filled capsule taken by mouth that contains three active ingredients commonly used to relieve cold and flu symptoms. Acetaminophen is typically used to reduce fever and ease pain or aches. Dextromethorphan is a cough suppressant. Phenylephrine is a nasal decongestant meant to help relieve stuffy nose. This product is marketed under the FDA's over-the-counter drug monograph system, which sets standard formulas and labeling for common cold and cough remedies.

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.

🧪 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 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesFD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution.

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.

💲 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.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 00904-6995-44 Major 1 capsule $0.130 — Availability likely —
good neighbor pharmacy day time cold and flu 325 mg/1; 10 mg/1; 5 mg 24385-0036-62 Amerisource 2 capsules $0.130 — Availability likely —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 70000-0515-01 CARDINAL 1 capsule $0.130 — Availability likely —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 70000-0752-01 CARDINAL 1 capsule $0.130 — Availability likely —
good sense daytime 325 mg/1; 10 mg/1; 5 mg 00113-0994-51 L. 2 capsules $0.138 — Discontinued —
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels 325 mg/1; 10 mg/1; 5 mg 00280-0095-01 Bayer 8 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00280-1590-20 Bayer 10 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels 10 mg/1; 5 mg/1; 325 mg 00280-1630-16 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels 10 mg/1; 5 mg/1; 325 mg 00280-8275-24 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels 325 mg/1; 10 mg/1; 5 mg 00280-8281-24 Bayer 8 capsules — — FDA listed —
Daytime Cold and Flu 5 mg/1; 10 mg/1; 325 mg 00363-0853-16 WALGREENS 8 capsules — — FDA listed —
Daytime Non-Drowsy Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00363-8998-16 Walgreens 8 capsules — — FDA listed —
Maximum Strength Congestion and Headache 325 mg/1; 10 mg/1; 5 mg 00363-9019-16 Walgreens 8 capsules — — FDA listed —
Daytime Ultra Concentrated Cold and Flu 5 mg/1; 325 mg/1; 10 mg 11673-0843-48 TARGET 48 capsules — — FDA listed —
Daytime Cold And Flu Multi Symptom 10 mg/1; 325 mg/1; 5 mg 11673-0975-24 TARGET 12 capsules — — FDA listed —
Multi-Symptom Cold And Flu Relief Daytime 5 mg/1; 325 mg/1; 10 mg 11822-1989-00 RITE 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 11822-3391-08 Rite 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0598-24 Safeway, 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0650-24 Safeway, 1 capsule — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 21130-0900-24 BETTER 12 capsules — — FDA listed —
Kroger Daytime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 30142-0087-48 The 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mgthis 35916-0155-01 SOFTGEL 12 capsules — — FDA listed —
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 5 mg/1; 10 mg/1; 325 mg 35916-0188-01 Softgel 1000 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 35916-0917-01 SOFTGEL 3000 capsules — — FDA listed —
Daytime 5 mg/1; 325 mg/1; 10 mg 37808-0093-16 H-E-B 8 capsules — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0848-16 H 1 capsule — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0864-16 H 1 capsule — — FDA listed —
day time 325 mg/1; 10 mg/1; 5 mg 37808-0994-60 H 2 capsules — — Discontinued —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 37835-0520-24 Bi-Mart 24 capsules — — FDA listed —
Daytime Cold and Flu Relief Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 41163-0848-24 United 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 41163-0998-24 United 1 capsule — — FDA listed —
Daytime Cold And Flu 10 mg/1; 5 mg/1; 325 mg 41226-0693-24 Kroger 12 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 41520-0068-24 Care 1 capsule — — Discontinued —
cold and flu 325 mg/1; 10 mg/1; 5 mg 42507-0700-62 HyVee 2 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 49035-0193-24 EQUATE 1 capsule — — FDA listed —
Daytime cold and flu 5 mg/1; 325 mg/1; 10 mg 49483-0693-48 TIME 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 51316-0896-24 CVS 1 capsule — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0004-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0025-01 Humanwell 4000 capsules — — FDA listed —
ASP Daytime PE 325 mg/1; 10 mg/1; 5 mg 53345-0052-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold/Flu Relief 325 mg/1; 10 mg/1; 5 mg 55301-0604-03 ARMY 12 capsules — — FDA listed —
Maximum Strenght Day Cold And Flu Formula 325 mg/1; 10 mg/1; 5 mg 55319-0933-22 FAMILY 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55319-0967-08 Family 1 capsule — — FDA listed —
Sanatos Daytime 325 mg/1; 10 mg/1; 5 mg 55758-0508-08 Pharmadel 8 capsules — — FDA listed —
Sanatos Daytime Relief 325 mg/1; 10 mg/1; 5 mg 55758-0514-08 Pharmadel 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55910-0982-08 Dolgencorp, 1 capsule — — FDA listed —
dg health cold plus flu relief 325 mg/1; 10 mg/1; 5 mg 55910-0994-51 Dolgencorp, 2 capsules — — Discontinued —
daytime 325 mg/1; 10 mg/1; 5 mg 56062-0417-62 Publix 2 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 57243-0604-03 SALADO 12 capsules — — FDA listed —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 58602-0768-15 Aurohealth 16 capsules — — FDA listed —
Kroger DayTime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 59450-0046-48 The 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0850-24 P 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0898-08 P 1 capsule — — Discontinued —
Mucinex Sinus-Max Severe Congestion and Pain 325 mg/1; 10 mg/1; 5 mg 63824-0692-16 Reckitt 8 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 63868-0736-24 QUALITY 1 capsule — — FDA listed —
Circle K Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-5571-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-6815-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 67091-0394-24 WinCo 1 capsule — — FDA listed —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 68016-0797-16 Chain 1 capsule — — FDA listed —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 68016-0877-16 Chain 16 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 68210-5053-01 Prodose, 3000 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 69168-0417-29 Allegiant 8 capsules — — FDA listed —
DayTime Cold Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69256-0898-24 Harris 1 capsule — — FDA listed —
Vicks DayQuil ULTRA CONCENTRATED COLD and FLU 5 mg/1; 325 mg/1; 10 mg 69423-0800-48 The 48 capsules — — FDA listed —
Vicks DayQuil COLD and FLU 325 mg/1; 10 mg/1; 5 mg 69423-0994-02 The 2 capsules — — FDA listed —
Day-Time Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 69517-0160-10 HealthLife 10 capsules — — FDA listed —
Activcin 10 mg/1; 325 mg/1; 5 mg 69729-0008-10 OPMX 10 capsules — — FDA listed —
Coldtac Plus Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0120-10 OPMX 10 capsules — — FDA listed —
Desresfriol-DX Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0121-10 OPMX 10 capsules — — FDA listed —
tabcin ACTIVE 10 mg/1; 325 mg/1; 5 mg 69729-0152-10 OPMX 10 capsules — — FDA listed —
Agrifen 325 mg/1; 5 mg/1; 10 mg 69729-0802-10 OPMX 10 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0848-16 CVS 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0897-24 CVS 1 capsule — — FDA listed —
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) 325 mg/1; 10 mg/1; 5 mg 71679-0101-00 Health 3000 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0005-01 Pioneer 48 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0062-01 Pioneer 48 capsules — — FDA listed —
Basic Care Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72288-0994-62 Amazon.com 2 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 72476-0848-24 Care 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72476-0898-24 Care 1 capsule — — FDA listed —
Mucinex Fast-Max Congestion and Headache Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0128-16 Reckitt 8 capsules — — FDA listed —
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0203-16 Reckitt 8 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 76162-0065-16 TopCo 16 capsules — — FDA listed —
Daytime Cold and Flu Max Maximum Strength Softgels 325 mg/1; 10 mg/1; 5 mg 76162-0912-24 Topco 12 capsules — — FDA listed —
Daytime Cold and Flu Relief Liquid Filled Softgels 325 mg/1; 10 mg/1; 5 mg 76281-0604-03 AptaPharma 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0807-04 Meijer, 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0827-04 Meijer, 12 capsules — — FDA listed —
Daytime Cold And Flu Relief 325 mg/1; 10 mg/1; 5 mg 80513-0303-50 Advanced 50 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 81522-0898-16 FSA 1 capsule — — FDA listed —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0023-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0050-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom mini softgels 325 mg/1; 10 mg/1; 5 mg 83059-0094-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0113-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0114-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0128-01 Shield 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 83324-0145-24 QUALITY 1 capsule — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0018-01 NUVICARE 10 capsules — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0023-01 NUVICARE 10 capsules — — FDA listed —
Dr. Simi Daytime Cold and Flu 10 mg/1; 325 mg/1; 5 mg 85786-0601-12 Farmacias 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 85828-0417-93 Grocery 24 capsules — — 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
35916-0155-01 You're viewing this 4 BLISTER PACK in 1 CARTON (35916-0155-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2024-08-15 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 35916-0155-1, 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: 35916-0155-01, written without dashes as 35916015501. 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 35916-0155-01, the first segment (35916) is the labeler code FDA assigned to SOFTGEL HEALTHCARE PRIVATE LIMITED; the middle segment (0155) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 SOFTGEL HEALTHCARE PRIVATE LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SOFTGEL HEALTHCARE PRIVATE LIMITED 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 24 words ▾

Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

⏱️ Dosage and Administration 43 words ▾

Directions take only as directed do not exceed 8 Softgels per 24 hrs adults & children 12 years & over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

⚠️ Warnings 104 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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.

🧪 Active Ingredient 19 words ▾

Active ingredient (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution.

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 35916-0154-01 · Softgel 35916-0166-01 · Softgel →
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.