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Acetaminophen Diphenhydramine HCL 500 mg; 25 mg Tablet, 75-count — NDC 0363-9799-75 (Billing 00363-9799-75)

by WALGREEN CO. · 75 TABLET in 1 BOTTLE

This is a package of 75 tablets of Acetaminophen Diphenhydramine HCL 500 mg; 25 mg Tablet from WALGREEN CO., marketed since Mar 2023 and currently FDA-listed. It is this product's only package size.

NDC 00363-9799-75
🏷️ FDA NDC (as labeled) 0363-9799-75 billing pads the labeler segment with a zero
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) 0363-9799-75
Product NDC 0363-9799
11-digit billing NDC 00363979975
RxCUI 1092189
UNII 362O9ITL9D, TC2D6JAD40
Application # M013
SPL Set ID b3763182-2428-155a-e053-2995a90ab578
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 2023-03-03
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1092189
Why two NDCs? The FDA registers this code as 0363-9799-75 — a 4-4-2 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 labeler segment → 00363-9799-75. 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 is this product?

This is an over-the-counter tablet taken by mouth that combines two active ingredients. Acetaminophen is commonly used to reduce fever and relieve minor aches and pains. Diphenhydramine hydrochloride is a first-generation antihistamine typically used to relieve allergy symptoms and is also known to cause drowsiness. Together, these ingredients are often found in nighttime pain and cold products intended for use when sleep may be desired.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00363-9799-75 You're viewing this Main listing 75 TABLET in 1 BOTTLE 2023-03-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense pain relief pm extra strength 500 mg/1; 25 mg 00113-0437-71 L. 50 tablets $0.044 — Availability likely —
Acetaminophen PM 25 mg/1; 500 mg 00904-6731-51 Major 50 tablets $0.044 — Availability likely —
Extra Strength PM Pain Medicine 500 mg/1; 25 mg 46122-0799-69 Amerisource 50 tablets $0.044 — Availability likely —
Acetaminophen, Diphenhydramine Hydrochloride 500 mg/1; 25 mg 70000-0411-01 LEADER/ 24 tablets $0.044 — Availability likely —
Pain Reliever PM 500 mg/1; 25 mg 70677-1149-01 Strategic 50 tablets $0.044 — Availability likely —
Acetaminophen PM 500 mg/1; 25 mg 83324-0070-20 Chain 20 tablets $0.044 — Availability likely —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 83324-0085-01 CHAIN 100 tablets $0.044 — Availability likely —
Pain Reliever PM 500 mg/1; 25 mg 83324-0166-50 QUALITY 50 tablets $0.044 — Availability likely —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0420-01 Strategic 50 tablets $0.046 — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0325-50 Chain 50 tablets $0.046 — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 70677-0081-01 Strategic 100 tablets $0.046 — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0256-01 Strategic 50 tablets $0.047 — FDA listed —
Panadol Pm 500 mg/1; 25 mg 00135-0608-01 Haleon 24 tablets — — FDA listed —
Panadol Pm 500 mg/1; 25 mg 00135-7021-01 Haleon 2 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0556-09 Walgreen 20 tablets — — FDA listed —
Extra Strength NiteTime Pain Relief 25 mg/1; 500 mg 00363-0714-42 WALGREENS 24 tablets — — FDA listed —
Extra Strength Nite-Time Pain Relief 500 mg/1; 25 mg 00363-0715-01 WALGREENS 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0760-10 Walgreens 100 tablets — — FDA listed —
Pain Reliever PM Extra strength 500 mg/1; 25 mg 00363-0863-10 Walgreens 100 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 00363-2035-08 Walgreen 24 tablets — — FDA listed —
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 00363-9085-15 WALGREENS 15 tablets — — FDA listed —
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mg 00363-9661-15 Walgreens 150 tablets — — FDA listed —
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mg 00363-9664-60 WALGREENS 125 tablets — — FDA listed —
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mgthis 00363-9799-75 WALGREEN 75 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 11673-0754-10 TARGET 100 tablets — — FDA listed —
Pain Relief Acetaminophen PM 500 mg/1; 25 mg 11822-0556-01 Rite 80 tablets — — FDA listed —
Pain Relief Acetaminophen PM Extra Strength 500 mg/1; 25 mg 11822-2350-02 Rite 100 tablets — — FDA listed —
Acetaminophen Pm 500 mg/1; 25 mg 17714-0133-50 Advance 50 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 21130-0095-01 Safeway 24 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 21130-0224-18 Better 80 tablets — — FDA listed —
Acetaminophen Diphenhydramine HCl 500 mg/1; 25 mg 21130-0354-02 BETTER 20 tablets — — FDA listed —
Acetaminophen and Diphenhydramine HCL 500 mg/1; 25 mg 21130-0661-10 SAFEWAY 100 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 30142-0193-14 KROGER 50 tablets — — FDA listed —
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 30142-0755-01 KROGER 100 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 36800-0095-03 TopCo 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 36800-0466-10 TOP 100 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 36800-0556-09 Topco 20 tablets — — FDA listed —
Vicks ZzzQuil Night Pain 25 mg/1; 500 mg 37000-0974-60 The 60 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0556-09 H 20 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0795-03 HEB 100 tablets — — FDA listed —
Acetaminophen and Diphenhydramine Hydrochloride 500 mg/1; 25 mg 37835-0537-01 Bi-Mart 100 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0228-50 United 50 tablets — — FDA listed —
acetaminophen pm extra strength 500 mg/1; 25 mg 41163-0515-01 United 24 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0956-09 United 20 tablets — — FDA listed —
pain relief PM 500 mg/1; 25 mg 41250-0195-02 Meijer 50 tablets — — FDA listed —
Acetaminophen and Diphenhydramine HCL 25 mg/1; 500 mg 41415-0661-05 PUBLIX 50 tablets — — FDA listed —
CareOne Acetaminophen PM 500 mg/1; 25 mg 41520-0514-47 American 150 tablets — — Discontinued —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41520-0956-09 FOODHOLD 20 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 42507-0095-03 HYVEE 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 49035-0363-10 EQUATE 100 tablets — — FDA listed —
Extra strength Acetaminophen PM 25 mg/1; 500 mg 49483-0430-40 TIME 400 tablets — — FDA listed —
Tylenol PM 500 mg/1; 25 mg 50269-0552-01 JC 2 tablets — — FDA listed —
Tylenol PM 500 mg/1; 25 mg 50269-0608-06 JC 25 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 50580-0608-01 Kenvue 24 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50594-0863-10 Big 100 tablets — — Discontinued —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 50804-0825-02 GoodSense 20 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0235-15 L.N.K. 50 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 50844-0256-08 L.N.K. 24 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0556-10 L.N.K. 40 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 51316-0863-50 CVS 500 tablets — — FDA listed —
CAREALL Non-Aspirin PM Extra Strength 500 mg/1; 25 mg 51824-0069-50 New 50 tablets — — FDA listed —
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0107-50 New 50 tablets — — FDA listed —
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0108-50 New 50 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 53209-1002-02 Morning 2 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 54257-0278-02 Magno-Humphries, 100 tablets — — FDA listed —
CounterAct PM 25 mg/1; 500 mg 54473-0304-01 Melaleuca, 50 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 55301-0235-06 ARMY 200 tablets — — Discontinued —
Pain Reliever PM 500 mg/1; 25 mg 55319-0562-10 Family 100 tablets — — FDA listed —
dg health pain relief pm extra strength 500 mg/1; 25 mg 55910-0437-71 Dolgencorp 50 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 55910-0655-10 DOLGENCORP, 40 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 55910-0834-01 DOLGENCORP, 100 tablets — — FDA listed —
pain relief pm extra strength 500 mg/1; 25 mg 56062-0437-71 Publix 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 57243-0235-15 Salado 50 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 57344-0095-01 AAA 24 tablets — — FDA listed —
Extra Strength Night Time Pain Medicine 500 mg/1; 25 mg 57896-0224-01 Geri-Care 100 tablets — — FDA listed —
Kroger EXTRA STRENGTH Acetaminophen PM Caplet 500 mg/1; 25 mg 59450-0174-01 The 100 tablets — — FDA listed —
Pain Reliever PM extra strength 500 mg/1; 25 mg 59726-0868-10 P 100 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 61504-0095-03 AMERIFOODS 100 tablets — — FDA listed —
Extra Strength Pain Reliever PM 500 mg/1; 25 mg 62936-0224-01 INGLES 50 tablets — — FDA listed —
good sense pain relief pm extra strength 500 mg/1; 25 mg 63629-5880-01 Bryant 14 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0119-50 QUALITY 50 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 63868-0210-20 CHAIN 20 tablets — — FDA listed —
Extra Strength Pain Relief PM 500 mg/1; 25 mg 63941-0095-02 VALU 50 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 63981-0056-54 COSTCO 375 tablets — — FDA listed —
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven 25 mg/1; 500 mg 66715-5640-04 Lil' 24 tablets — — FDA listed —
Tylenol PM Extra Strength, CVP HEALTH 25 mg/1; 500 mg 66715-6417-02 Lil' 2 tablets — — FDA listed —
Tylenol PM Extra Strength, CVP HEALTH 500 mg/1; 25 mg 66715-6517-02 Lil' 2 tablets — — FDA listed —
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven 25 mg/1; 500 mg 66715-8158-03 Lil' 6 tablets — — FDA listed —
Lil Drug Store Tylenol PM Extra Strength 25 mg/1; 500 mg 66715-9817-02 Lil' 2 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 67091-0137-50 WinCo 50 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 67414-0608-00 Jones 2 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 67751-0241-01 Navajo 2 tablets — — FDA listed —
Acetaminophen Diphenhydramine HCl 500 mg/1; 25 mg 68016-0654-05 Chain 50 tablets — — FDA listed —
acetaminophen pm extra strength 500 mg/1; 25 mg 68196-0556-54 Sam's 375 tablets — — FDA listed —
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 68391-0430-50 BJWC 500 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 68391-0863-05 BJWC 500 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0071-03 MARC 80 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0195-02 MARC 50 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 69168-0003-50 Allegiant 50 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 69168-0393-02 Allegiant 150 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 69607-8630-01 WR 24 tablets — — FDA listed —
Genexa Acetaminophen PM Extra Strength 500 mg/1; 25 mg 69676-0063-02 Genexa 100 tablets — — FDA listed —
Cystex PM 500 mg/1; 25 mg 69693-0417-10 Clarion 10 tablets — — FDA listed —
Acetaminophen, Diphenhydramine Hcl 25 mg/1; 500 mg 69842-0572-08 CVS 24 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 69842-0956-09 CVS 20 tablets — — Discontinued —
Acetaminophen Diphenhydramine HCl 25 mg/1; 500 mg 69848-0014-02 Granules 20 tablets — — FDA listed —
Tylenol Pm Extra Strength 500 mg/1; 25 mg 70264-0028-01 R 2 tablets — — FDA listed —
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief 500 mg/1; 25 mg 70692-0149-03 Strive 30 tablets — — FDA listed —
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet 500 mg/1; 25 mg 70692-0471-31 Strive 300 tablets — — FDA listed —
GOOD REMEDIES Extra Strength Pain Relief PM Caplet 500 mg/1; 25 mg 70692-0741-03 Strive 30 tablets — — FDA listed —
pain relief PM 500 mg/1; 25 mg 72036-0095-02 HARRIS 50 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 72036-0171-02 Harris 40 tablets — — FDA listed —
Pain Relief PM 25 mg/1; 500 mg 72090-0006-25 Pioneer 375 tablets — — FDA listed —
Pain Relief PM 25 mg/1; 500 mg 72090-0032-01 Pioneer 375 tablets — — FDA listed —
basic care acetaminophen pm 500 mg/1; 25 mg 72288-0437-78 Amazon.com 100 tablets — — FDA listed —
Acetaminophen Pm 500 mg/1; 25 mg 72476-0171-01 RETAIL 20 tablets — — FDA listed —
Acetaminophen Pm 500 mg/1; 25 mg 73057-0352-03 Ulai 24 tablets — — FDA listed —
Tylenol PM 500 mg/1; 25 mg 73097-0013-02 Savings 2 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 76168-0119-25 Velocity 50 tablets — — FDA listed —
meijer EXTRA STRENGTH Pain Relief PM Caplet 500 mg/1; 25 mg 79481-0149-01 Meijer, 100 tablets — — FDA listed —
meijer EXTRA STRENGTH Pain Relief PM CAPLET 500 mg/1; 25 mg 79481-0174-01 Meijer, 100 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 79903-0050-09 WALMART 20 tablets — — FDA listed —
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 79903-0053-10 WALMART 100 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 79903-0267-80 WALMART 80 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 79903-0298-10 Walmart 100 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 79903-0307-10 WALMART 100 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 81522-0095-03 FSA 100 tablets — — FDA listed —
NOTTS - Pain Relief PM 500 mg/1; 25 mg 82706-0009-01 VIVUNT 24 tablets — — FDA listed —
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength 500 mg/1; 25 mg 82725-1024-01 Cabinet 375 tablets — — FDA listed —
Goodmeds Extra Strength Pain Relief PM 500 mg/1; 25 mg 82725-4124-01 Cabinet 375 tablets — — FDA listed —
Pain Relief PM 25 mg/1; 500 mg 84324-0005-01 NUVICARE 100 tablets — — FDA listed —
Dr Simi Pain Reliever PM 500 mg/1; 25 mg 85786-0101-90 Farmacias 100 tablets — — FDA listed —
Dr. Simi Pain Reliever PM 25 mg/1; 500 mg 85786-0108-24 Farmacias 24 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 85828-0095-03 Grocery 100 tablets — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statesammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide. colloidal silicon dioxide, croscarmellose sodium, D7C red#28, D&C yellow#10, FD7C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

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

LabelerWALGREEN CO.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio132 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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 51 words ▾

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

⏱️ Dosage and Administration 111 words ▾

Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor

Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps at bedtime ■ do not take more than 2 gelcaps of this product in 24 hours children under 12 years ■ do not use

⚠️ Warnings 146 words ▾

Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4,000 mg of acetaminophen in 24 hours ■ 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.

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ 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.

🆘 Overdosage 92 words ▾

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

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 48 words ▾

Other information ■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date

Other information ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. ■ see end panel for lot number and expiration date

🧪 Active Ingredient 28 words ▾

Acetaminophen Gelcaps Active Ingredient (in each Gelcap) Acetaminophen USP, 500 mg

Acetaminophen PM Gelcaps Active ingredient (in each gelcap) Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

🧪 Inactive Ingredients 94 words ▾

Inactive ingredients ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D7C red#28, D&C yellow#10, FD7C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

🎯 Purpose 10 words ▾

Purpose Pain reliever/fever reducer

Purposes Pain reliever Nighttime sleep aid

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

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 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 WALGREEN CO.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WALGREEN CO. 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.
← 00363-9798-05 · WALGREEN 00363-9800-01 · Walgreen →
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.