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Benadryl Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated — NDC 85237-1960-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benadryl Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated — NDC 85237-1960-4 (Billing 85237-1960-04)

by Select Consumer Group · 25 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH

This is a package of Benadryl Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated from Select Consumer Group, marketed since Sep 2008 and currently FDA-listed.

NDC 85237-1960-04
🏷️ FDA NDC (as labeled) 85237-1960-4 billing pads the package segment with a zero
This package
Contains2 tablet, film coated in 1 pouch Pack sizes6 compare ↓
Product page 85237-1960-01 Also comes in: 2 tablets 85237-1960-1 2 tablets 85237-1960-2 2 tablets 85237-1960-3 2 tablets 85237-1960-5 2 tablets 85237-1960-7
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) 85237-1960-4
Product NDC 85237-1960
11-digit billing NDC 85237196004
RxCUI 1049630, 1049632
UNII TC2D6JAD40
Application # M012
SPL Set ID 55d10292-e673-9896-e063-6294a90a5674
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 2008-09-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1049630
Why two NDCs? The FDA registers this code as 85237-1960-4 — 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 → 85237-1960-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

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

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

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer 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: 2 tablets 2 tablets 2 tablets 2 tablets 2 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
85237-1960-01 85237-1960-1 Main listing 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2012-06-04 — Active
85237-1960-02 85237-1960-2 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2012-06-04 — Active
85237-1960-03 85237-1960-3 20 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH 2012-06-04 — Active
85237-1960-04 You're viewing this 25 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH 2012-06-04 — Active
85237-1960-05 85237-1960-5 30 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH 2012-06-04 — Active
85237-1960-07 85237-1960-7 3 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2025-06-04 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 pouch in 1 carton / 2 tablet, film coated in 1 pouch.
What NDC number is used to bill for this package of Benadryl 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 mgthis 85237-1960-04 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 mg 72288-0391-01 Amazon.com 400 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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 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.

What it looks like

Color pink
ShapeOval
ImprintB;WL;25
Size11 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • 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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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.

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

The official label also statescarnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

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

LabelerSelect Consumer Group
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code85237
First marketedSep 2008
Product typeHuman Otc Drug
Portfolio21 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 38 words ▾

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

⏱️ Dosage and Administration 49 words ▾

Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times 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 126 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 25 words ▾

Other information each tablet contains: calcium 15 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 19 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 26 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 34 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 9 words ▾

Questions or comments? call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL 1960-1

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Benadryl (this brand).

Top reported reactions

Fatigue11,124
Nausea9,778
Headache9,014
Pain7,995
Pruritus7,441
Dyspnoea7,327
Infusion Related Reaction6,902

Age at onset

Neonate62
Infant81
Child615
Adolescent733
Adult11,559
Elderly4,367

Reporter sex

93,307 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Death8,271
Life-threatening3,658
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,935 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Select Consumer Group. 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 5 other package presentations of this same product, including 2 tablets (85237-1960-01), 2 tablets (85237-1960-02), 2 tablets (85237-1960-03). 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?
Select Consumer Group 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.
← 85237-1956-01 · Select 85237-2945-01 · Select →
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.