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Allergy Relief Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated, 100-count — NDC 72288-0391-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Allergy Relief Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated, 100-count — NDC 72288-391-78 (Billing 72288-0391-78)

by Amazon.com Services LLC · 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Allergy Relief Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated from Amazon.com Services LLC, marketed since Aug 2026 and currently FDA-listed.

NDC 72288-0391-78
🏷️ FDA NDC (as labeled) 72288-391-78 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Product page 72288-0391-01 Also comes in: 400 tablets 72288-391-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 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) 72288-391-78
Product NDC 72288-391
11-digit billing NDC 72288039178
RxCUI 1049630
UNII TC2D6JAD40
Application # M012
SPL Set ID 298e9164-e378-4b39-a944-bfc8f8baa4de
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 2026-08-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1049630
Why two NDCs? The FDA registers this code as 72288-391-78 — 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 → 72288-0391-78. 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

📗 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 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.
Try another pack size: 400 tablets
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
72288-0391-01 72288-391-01 Main listing 400 TABLET, FILM COATED in 1 BOTTLE 2026-08-27 — Active
72288-0391-78 You're viewing this 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE 2026-08-27 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 72288-0391-01?
Both are Allergy Relief Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 72288-0391-01 is the 400 tablets package.
What NDC number is used to bill for this package of Allergy Relief Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenhydramine Hydrochloride 25 mg 68094-0018-61 Precision 100 tablets $0.037 — Availability likely —
good sense allergy relief 25 mg 00113-0479-62 L. 24 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 83324-0088-01 CHAIN 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 49483-0061-01 TIME 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70677-1238-01 Strategic 120 tablets $0.037 — Availability likely —
Nighttime Sleep Aid 25 mg 83324-0110-32 CHAIN 32 tablets $0.060 — Availability likely —
Rest Simply 25 mg 83324-0113-01 CHAIN 100 tablets $0.060 — Availability likely —
good sense nighttime sleep aid 25 mg 00113-0431-62 L. 2 tablets $0.060 — Availability likely —
Nighttime Sleep Aid 25 mg 63868-0611-32 Chain 32 tablets $0.066 — FDA listed —
Diphenhydramine Hydrochloride 25 mg 17714-0135-01 Advance 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 49483-0329-00 Time-Cap 100000 tablets — — FDA listed —
Sleep Aid 25 mg 76168-0015-07 Velocity 36 tablets — — FDA listed —
Allergy 25 mg 76168-0121-12 Velocity 100 tablets — — FDA listed —
Allergy Relief 25 mg 61504-0090-03 AMERIFOODS 100 tablets — — FDA listed —
Circle K Allergy Antihistamine 25 mg 66715-5554-02 Lil' 2 tablets — — Discontinued —
Benadryl Allergy Ultratab 25 mg 67414-0226-00 Jones 2 tablets — — FDA listed —
Benadryl 25 mg 71205-0521-06 Proficient 2 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mg 76457-0002-00 Simpex 100 tablets — — FDA listed —
Allergy Relief 25 mg 36800-0909-01 TopCo 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37808-0019-02 HEB 32 tablets — — FDA listed —
careone nighttime sleep aid 25 mg 41520-0431-62 American 2 tablets — — FDA listed —
Benadryl Ultra Tab 25 mg 50269-0226-54 JC 25 tablets — — FDA listed —
Simply Sleep 25 mg 50580-0843-12 Kenvue 100 tablets — — FDA listed —
Rest Simply 25 mg 53943-0191-01 DISCOUNT 6 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0219-01 VALU 16 tablets — — FDA listed —
Benadryl 25 mg 66715-6406-02 Lil' 2 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9024-60 Walgreens 600 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0834-51 CVS 365 tablets — — FDA listed —
GOOD REMEDIES Nighttime Sleep Aid Caplets 25 mg 70692-0011-06 Strive 60 tablets — — FDA listed —
Somnitabs 25 mg 72036-0019-02 HARRIS 32 tablets — — FDA listed —
Rest Simply 25 mg 72036-0091-01 Harris 12 tablets — — FDA listed —
Allergy Relief 25 mg 82725-1001-01 Cabinet 600 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4101-01 Cabinet 600 tablets — — FDA listed —
Good Neighbor Pharmacy allergy 25 mg 24385-0479-62 Amerisource 24 tablets — — Discontinued —
topcare sleep aid nighttime 25 mg 36800-0431-62 Topco 2 tablets — — FDA listed —
nighttime sleep aid 25 mg 37808-0431-62 H 2 tablets — — FDA listed —
CAREALL Diphenhydramine 25 mg 51824-0056-01 New 100 tablets — — FDA listed —
Benadryl 25 mg 53209-3001-02 Morning 2 tablets — — FDA listed —
Allergy Relief 25 mg 00363-0100-61 WALGREENS 600 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 70692-0151-46 Strive 72 tablets — — FDA listed —
Medique Diphen 25 mg 47682-0167-46 Unifirst 1 tablet — — FDA listed —
Nyt Time Sleep Caps 25 mg 53943-0128-03 DISCOUNT 72 tablets — — FDA listed —
Rest Simply 25 mg 63868-0772-10 Chain 100 tablets — — FDA listed —
Sominex 25 mg 67751-0221-01 Navajo 8 tablets — — FDA listed —
Rest Simply 25 mg 68998-0091-01 Marc 12 tablets — — FDA listed —
GOOD REMEDIES Allergy Relief 25 mg 70692-0022-06 Strive 60 tablets — — FDA listed —
Allergy Relief 25 mg 71679-0106-06 Health 600 tablets — — FDA listed —
Allergy Relief 25 mg 72036-0090-01 Harris 12 tablets — — FDA listed —
AXIV Allergy Relief 25 mg 82706-0021-02 VIVUNT 100 tablets — — FDA listed —
Allergy Relief 25 mg 37808-0590-02 HEB 12 tablets — — FDA listed —
Allergy Relief 25 mg 42507-0290-01 HYVEE 12 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0191-00 CVS 365 tablets — — FDA listed —
Allergy Relief 25 mg 55681-0323-03 TWIN 300 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0959-24 DOLGENCORP, 24 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 57344-0091-03 AAA 100 tablets — — FDA listed —
Benadryl Allergy Ultratab 25 mg 73097-0004-02 Savings 2 tablets — — FDA listed —
equate allergy relief 25 mg 79903-0297-10 WALMART 100 tablets — — FDA listed —
Betr sleep aid 25 mg 80267-0431-67 Live 2 tablets — — FDA listed —
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl 25 mg 82725-1101-01 Cabinet 600 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 37835-0641-01 Bi-Mart 100 tablets — — FDA listed —
allergy 25 mg 41250-0479-53 Meijer 12 tablets — — Discontinued —
Rest Simply 25 mg 42507-0291-03 HYVEE 100 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mg 51662-1674-01 HF 1 tablet — — FDA listed —
Benadryl Ultratabs 25 mg 67751-0166-01 Navajo 2 tablets — — FDA listed —
meijer Allergy Relief 25 mg 79481-0148-04 Meijer, 24 tablets — — FDA listed —
Dormmy-Lon 25 mg 83164-0000-01 Haendel 60 tablets — — FDA listed —
Allergy 25 mg 41226-0160-01 Kroger 100 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0186-25 CVS 365 tablets — — FDA listed —
allergy 25 mg 56062-0479-62 Publix 24 tablets — — Discontinued —
welby allergy relief 25 mg 64024-0479-78 Aldi 100 tablets — — FDA listed —
Allergy Relief 25 mg 68391-0160-33 BJWC 600 tablets — — FDA listed —
Cabinet Allergy Relief Refill Diphenhydramine HCI 25 mg 82725-3001-02 Cabinet 120 tablets — — FDA listed —
Allergy Relief 25 mg 83059-0021-03 Shield 36 tablets — — FDA listed —
careone allergy relief 25 mg 41520-0778-62 American 24 tablets — — Discontinued —
Benadryl 25 mg 50580-0226-50 Kenvue 100 tablets — — FDA listed —
CAREALL Allergy Relief 25 mg 51824-0102-01 New 100 tablets — — FDA listed —
dg health sleep aid 25 mg 55910-0431-62 Dolgencorp 2 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 56062-0091-01 PUBLIX 6 tablets — — FDA listed —
Diphenhydramine 25 mg 57344-0090-02 AAA 12 tablets — — FDA listed —
Allergy Relief 25 mg 63941-0090-01 VALU 12 tablets — — FDA listed —
Benadryl 25 mg 66715-9706-02 Lil' 2 tablets — — FDA listed —
Benadryl Allergy 25 mg 70264-0024-01 R 2 tablets — — FDA listed —
Allergy Relief 25 mg 79903-0056-10 Wal-Mart 100 tablets — — FDA listed —
Goodmeds Allergy Relief 25 mg 82725-4201-01 Cabinet 600 tablets — — FDA listed —
Allergy Relief Caplet 25 mg 36800-0937-40 TOPCO 400 tablets — — FDA listed —
Allergy 25 mg 53943-0090-01 Discount 12 tablets — — FDA listed —
Nighttime SleepAid 25 mg 61504-0091-03 AMERIFOODS 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0091-01 VALU 6 tablets — — FDA listed —
Benadryl 25 mg 66715-6506-02 Lil' 2 tablets — — FDA listed —
Berkley and Jensen Allergy Relief 25 mg 68391-0200-79 BJWC 400 tablets — — FDA listed —
basic care allergy relief 25 mg 72288-0479-78 Amazon.com 100 tablets — — FDA listed —
equate nighttime sleep aid 25 mg 79903-0274-36 WALMART 365 tablets — — FDA listed —
Allergy Relief 25 mg 81522-0109-03 FSA 100 tablets — — FDA listed —
PhysiciansCare Allergy Antihistamine 25 mg 00924-0056-01 Acme 1 tablet — — FDA listed —
Allergy Relief 25 mg 41163-0290-03 United 100 tablets — — FDA listed —
Allergy Relief 25 mg 41520-0290-11 FOODHOLD 300 tablets — — FDA listed —
Benadryl Allergy 25 mg 50269-0528-00 JC 20 tablets — — FDA listed —
Allergy Relief 25 mg 53942-0190-05 Demoulas 400 tablets — — FDA listed —
DG Health Allergy 25 mg 55910-0479-78 Dolgencorp 100 tablets — — Discontinued —
Kroger Nighttime Sleep Aid CAPLET 25 mg 59450-0601-01 The 100 tablets — — FDA listed —
Allergy Relief 25 mg 63868-0492-10 Chain 100 tablets — — FDA listed —
Allergy Relief 25 mg 68196-0160-60 SAM'S 600 tablets — — FDA listed —
meijer NIGHTTIME Sleep Aid CAPLET 25 mg 79481-0151-01 Meijer, 100 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4001-01 Cabinet 600 tablets — — FDA listed —
Sominex 25 mg 63029-0554-01 Medtech 8 tablets — — FDA listed —
Allergy Relief 25 mg 68998-0090-03 Marc 100 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9023-36 Walgreens 365 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0981-08 CVS 200 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71679-0308-00 Health 100000 tablets — — FDA listed —
Benadryl 25 mg 85237-1960-01 Select 2 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71679-0311-00 Health 100000 tablets — — FDA listed —
DG Health Allergy Relief 25 mg 55910-0923-78 Dolgencorp 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 55154-1589-00 Cardinal 10 tablets — — FDA listed —
Allergy Relief 25 mgthis 72288-0391-78 Amazon.com 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

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

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

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

What it looks like

Color Pink
ShapeOval
ImprintL479;25
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • 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 ZK64F7XSTX
    A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statesanhydrous citric acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, stearic acid, talc, 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

LabelerAmazon.com Services LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code72288
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio345 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses temporarily relieves symptoms due to hay fever, or other upper respiratory allergies and the common cold

⏱️ Dosage and Administration 51 words ▾

Directions • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

⚠️ Warnings 136 words ▾

Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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 If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 17 words ▾

Other information • store at 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 34 words ▾

Inactive ingredients anhydrous citric acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, stearic acid, talc, titanium dioxide, triacetin

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 21 words ▾

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

📄 Ask a Doctor Before Use If 29 words ▾

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

📄 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

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 35 words ▾

Principal Display Panel amazon basics Compare to Benadryl ® active ingredient Multi-Symptom Allergy Relief Diphenhydramine HCl 25 mg – Antihistamine Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat 400 TABLETS actual size Allergy Relief Label

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 ✓ 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 Amazon.com Services LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 400 tablets (72288-0391-01). 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?
Amazon.com Services LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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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.