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Allergy Relief Diphenhydramine HCl 25 mg Tablet, 100-count — NDC 69517-0003-01 package photo

Allergy Relief Diphenhydramine HCl 25 mg Tablet, 100-count

by HealthLife of USA LLC · 100 TABLET in 1 BOTTLE (69517-003-01)
NDC 69517-0003-01
🏷️ FDA NDC (as labeled) 69517-003-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also comes in: 300 tablets 69517-0003-03 600 tablets 69517-0003-06 1000 tablets 69517-0003-10
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 69517-003-01
Product NDC 69517-003
11-digit billing NDC 69517000301
RxCUI 1049630
UNII TC2D6JAD40
UPC 0369517003103
Application # M012
SPL Set ID a73d20df-3df7-42f7-8c88-93fee7e9ccec
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 Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-09-17
Route ORAL
Dosage form TABLET
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 69517-003-01 — 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 → 69517-0003-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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.

🏭 Manufacturer & labeler

LabelerHealthLife of USA LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69517
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio9 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 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.

💊 What it looks like

Color pink
ShapeCapsule
ImprintD25
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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • 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 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • 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 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 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.

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

The official label also statesColloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27,  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.

💲 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: 300 tablets 600 tablets 1000 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense allergy relief 25 mg 00113-0479-62 L. 24 tablets $0.037 — Availability likely —
Diphenhydramine HCl 25 mg 00536-1214-29 Rugby 100 tablets $0.037 — Availability likely —
Banophen 25 mg 00904-5551-24 Major 12 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 46122-0441-62 Amerisource 12 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 49483-0061-01 TIME 100 tablets $0.037 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 68094-0018-61 Precision 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70000-0136-01 Cardinal 12 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70677-1014-01 Strategic 12 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70677-1238-01 Strategic 120 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 83324-0088-01 CHAIN 100 tablets $0.037 — Availability likely —
good sense nighttime sleep aid 25 mg 00113-0431-62 L. 2 tablets $0.060 — Availability likely —
Sleep Tabs 25 mg 00904-4274-51 Major 50 tablets $0.060 — Availability likely —
Sleep Aid 25 mg 46122-0651-62 Amerisource 12 tablets $0.060 — Availability likely —
Nighttime Sleep Aid 25 mg 70677-1128-01 Strategic 12 tablets $0.060 — 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 —
Nighttime Sleep Aid 25 mg 63868-0611-32 Chain 32 tablets $0.066 — FDA listed —
Sleep Aid 25 mg 70000-0244-01 Cardinal 12 tablets $0.066 — FDA listed —
Allergy Relief 25 mg 00363-0100-61 WALGREENS 600 tablets — — FDA listed —
Sleep II Nighttime Sleep Aid 25 mg 00363-0189-46 Walgreen 96 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 00363-0367-08 Walgreen 12 tablets — — FDA listed —
Allergy Relief 25 mg 00363-3291-08 Walgreen 12 tablets — — FDA listed —
Allergy Relief 25 mg 00363-6141-12 Walgreen 100 tablets — — FDA listed —
Sleep Aid 25 mg 00363-6720-12 Walgreen 100 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9023-36 Walgreens 365 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9024-60 Walgreens 600 tablets — — FDA listed —
PhysiciansCare Allergy Antihistamine 25 mg 00924-0056-01 Acme 1 tablet — — FDA listed —
Allergy Relief 25 mg 11673-0494-01 TARGET 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 11673-0496-01 TARGET 100 tablets — — FDA listed —
Allergy Relief 25 mg 11822-0329-01 Rite 365 tablets — — FDA listed —
sleep aid 25 mg 11822-0672-06 Rite 200 tablets — — FDA listed —
Sleep Aid 25 mg 11822-3670-02 Rite 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 17714-0135-01 Advance 100 tablets — — FDA listed —
Allergy Relief 25 mg 21130-0329-06 Better 200 tablets — — Discontinued —
Allergy Relief 25 mg 21130-0596-01 BETTER 100 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 21130-0763-06 Better 200 tablets — — FDA listed —
Good Neighbor Pharmacy allergy 25 mg 24385-0479-62 Amerisource 24 tablets — — Discontinued —
Allergy Relief 25 mg 29485-9285-02 Lil' 2 tablets — — FDA listed —
topcare sleep aid nighttime 25 mg 36800-0431-62 Topco 2 tablets — — FDA listed —
Sleep Aid 25 mg 36800-0672-06 Topco 200 tablets — — FDA listed —
Allergy Relief 25 mg 36800-0909-01 TopCo 12 tablets — — FDA listed —
Allergy Relief Caplet 25 mg 36800-0937-40 TOPCO 400 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37808-0019-02 HEB 32 tablets — — FDA listed —
nighttime sleep aid 25 mg 37808-0431-62 H 2 tablets — — FDA listed —
Allergy Relief 25 mg 37808-0590-02 HEB 12 tablets — — FDA listed —
Allergy Relief 25 mg 37808-0932-08 H 12 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 37835-0641-01 Bi-Mart 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37835-0812-36 Bi-Mart 36 tablets — — FDA listed —
Allergy Relief 25 mg 41163-0290-03 United 100 tablets — — FDA listed —
Allergy Relief 25 mg 41163-0329-08 United 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 41163-0367-06 United 200 tablets — — FDA listed —
Allergy 25 mg 41226-0160-01 Kroger 100 tablets — — FDA listed —
allergy 25 mg 41250-0479-53 Meijer 12 tablets — — Discontinued —
allergy relief 25 mg 41250-0614-12 Meijer 100 tablets — — FDA listed —
Allergy Relief 25 mg 41520-0290-11 FOODHOLD 300 tablets — — FDA listed —
careone nighttime sleep aid 25 mg 41520-0431-62 American 2 tablets — — FDA listed —
careone allergy relief 25 mg 41520-0778-62 American 24 tablets — — Discontinued —
Allergy Relief 25 mg 42507-0290-01 HYVEE 12 tablets — — FDA listed —
Rest Simply 25 mg 42507-0291-03 HYVEE 100 tablets — — FDA listed —
Medique at Home Diphen 25 mg 47682-0166-50 Unifirst 1 tablet — — FDA listed —
Medique Diphen 25 mg 47682-0167-46 Unifirst 1 tablet — — FDA listed —
Allergy Relief 25 mg 49035-0164-12 Wal-Mart 100 tablets — — Discontinued —
Sleep Aid Nighttime 25 mg 49035-0367-08 Wal-Mart 12 tablets — — FDA listed —
Sleep Aid NightTime 25 mg 49035-0672-51 Wal-Mart 365 tablets — — FDA listed —
Allergy Relief 25 mg 49035-0929-12 Wal-Mart 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 49483-0329-00 Time-Cap 100000 tablets — — FDA listed —
Banophen 25 mg 50090-5546-00 A-S 12 tablets — — FDA listed —
Benadryl Ultra Tab 25 mg 50269-0226-54 JC 25 tablets — — FDA listed —
Benadryl Allergy 25 mg 50269-0528-00 JC 20 tablets — — FDA listed —
Histaprin 25 mg 50332-0150-04 NorMed 50 tablets — — FDA listed —
Benadryl 25 mg 50580-0226-50 Kenvue 100 tablets — — FDA listed —
Benadryl 50580-0370-01 Kenvue 100 tablets — — FDA listed —
Simply Sleep 25 mg 50580-0843-12 Kenvue 100 tablets — — FDA listed —
Allergy Relief 25 mg 50804-0048-93 Good 24 tablets — — FDA listed —
Allergy Relief 25 mg 50844-0229-08 L.N.K. 12 tablets — — FDA listed —
Allergy Relief 25 mg 50844-0329-02 L.N.K. 12 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0186-25 CVS 365 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0191-00 CVS 365 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 51316-0367-12 CVS 100 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mg 51662-1674-01 HF 1 tablet — — FDA listed —
CAREALL Diphenhydramine 25 mg 51824-0056-01 New 100 tablets — — FDA listed —
CAREALL Allergy Relief 25 mg 51824-0102-01 New 100 tablets — — FDA listed —
Benadryl 25 mg 53209-3001-02 Morning 2 tablets — — FDA listed —
Allergy Relief 25 mg 53942-0190-05 Demoulas 400 tablets — — FDA listed —
Allergy 25 mg 53943-0090-01 Discount 12 tablets — — FDA listed —
Nyt Time Sleep Caps 25 mg 53943-0128-03 DISCOUNT 72 tablets — — FDA listed —
Rest Simply 25 mg 53943-0191-01 DISCOUNT 6 tablets — — FDA listed —
Sleep-Aid 25 mg 55301-0189-23 ARMY 72 tablets — — FDA listed —
Allergy Relief 25 mg 55301-0329-12 ARMY 100 tablets — — FDA listed —
Allergy Relief 25 mg 55319-0329-02 Family 12 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 55319-0367-08 Family 12 tablets — — FDA listed —
Allergy Relief 25 mg 55681-0323-03 TWIN 300 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0293-08 DOLGENCORP, 12 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0329-51 DOLGENCORP, 365 tablets — — FDA listed —
dg health sleep aid 25 mg 55910-0431-62 Dolgencorp 2 tablets — — FDA listed —
DG Health Allergy 25 mg 55910-0479-78 Dolgencorp 100 tablets — — Discontinued —
Sleep Aid 25 mg 55910-0614-12 DOLGENCORP, 100 tablets — — FDA listed —
Sleep Aid Night Time 25 mg 55910-0687-08 DOLGENCORP, 12 tablets — — FDA listed —
Sleep Aid Night Time 25 mg 55910-0772-51 DOLGENCORP, 365 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0959-24 DOLGENCORP, 24 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 56062-0091-01 PUBLIX 6 tablets — — FDA listed —
allergy 25 mg 56062-0479-62 Publix 24 tablets — — Discontinued —
Allergy 25 mg 56062-0923-08 Publix 12 tablets — — FDA listed —
Sleep 25 mg 57243-0189-21 Salado 16 tablets — — FDA listed —
Diphenhydramine 25 mg 57344-0090-02 AAA 12 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 57344-0091-03 AAA 100 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 57896-0683-01 Geri-Care 100 tablets — — FDA listed —
Nighttime Sleep-aid 25 mg 57896-0785-72 Geri-Care 72 tablets — — FDA listed —
Kroger Nighttime Sleep Aid CAPLET 25 mg 59450-0601-01 The 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 59779-0367-08 CVS 12 tablets — — Discontinued —
Allergy Relief Dye-Free 25 mg 59779-0614-06 CVS 200 tablets — — FDA listed —
Allergy Relief 25 mg 59779-0923-03 CVS 10 tablets — — FDA listed —
Allergy Relief 25 mg 61504-0090-03 AMERIFOODS 100 tablets — — FDA listed —
Nighttime SleepAid 25 mg 61504-0091-03 AMERIFOODS 100 tablets — — FDA listed —
Nytol 25 mg 63029-0211-01 Medtech 32 tablets — — FDA listed —
Sominex 25 mg 63029-0554-01 Medtech 8 tablets — — FDA listed —
Allergy Relief 25 mg 63868-0492-10 Chain 100 tablets — — FDA listed —
Rest Simply 25 mg 63868-0772-10 Chain 100 tablets — — FDA listed —
Allergy Relief 25 mg 63941-0090-01 VALU 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0091-01 VALU 6 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0219-01 VALU 16 tablets — — FDA listed —
Allergy Medicine 25 mg 63981-0329-78 COSTCO 600 tablets — — FDA listed —
welby allergy relief 25 mg 64024-0479-78 Aldi 100 tablets — — FDA listed —
Allergy, Circle K 25 mg 66715-5154-08 Lil' 12 tablets — — FDA listed —
Sleep-Aid, Circle K 25 mg 66715-5503-08 Lil' 12 tablets — — FDA listed —
Circle K Allergy Antihistamine 25 mg 66715-5554-02 Lil' 2 tablets — — Discontinued —
Allergy 36ct, Caseys 4good 25 mg 66715-6314-08 Lil' 12 tablets — — FDA listed —
Benadryl 25 mg 66715-6406-02 Lil' 2 tablets — — FDA listed —
Benadryl 25 mg 66715-6506-02 Lil' 2 tablets — — FDA listed —
Allergy Relief, 24-7 Lift by 7-Eleven 25 mg 66715-6514-08 Lil' 12 tablets — — FDA listed —
Sleep-Aid, Lil Drug Store 25 mg 66715-6643-08 Lil' 12 tablets — — FDA listed —
Allergy, Lil Drug Store 25 mg 66715-6914-08 Lil' 12 tablets — — FDA listed —
Allergy Relief, 24-7 Life by 7-Eleven 25 mg 66715-8157-03 Lil' 6 tablets — — FDA listed —
Benadryl 25 mg 66715-9706-02 Lil' 2 tablets — — FDA listed —
Allergy 25 mg 66715-9711-07 Lil' 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 67091-0115-10 WinCo 100 tablets — — FDA listed —
Allergy Relief Complete 25 mg 67091-0200-10 WinCo 100 tablets — — FDA listed —
Sleep Aid 25 mg 67091-0339-24 WinCo 12 tablets — — FDA listed —
Benadryl Allergy Ultratab 25 mg 67414-0226-00 Jones 2 tablets — — FDA listed —
Benadryl Ultratabs 25 mg 67751-0166-01 Navajo 2 tablets — — FDA listed —
Sominex 25 mg 67751-0221-01 Navajo 8 tablets — — FDA listed —
Allergy Relief 25 mg 68196-0160-60 SAM'S 600 tablets — — FDA listed —
Aller-Ben 25 mg 68196-0829-78 Sam's 600 tablets — — Discontinued —
Allergy Relief 25 mg 68391-0160-33 BJWC 600 tablets — — FDA listed —
Berkley and Jensen Allergy Relief 25 mg 68391-0200-79 BJWC 400 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 68788-8104-00 Preferred 10 tablets — — FDA listed —
Allergy Relief 25 mg 68998-0090-03 Marc 100 tablets — — FDA listed —
Rest Simply 25 mg 68998-0091-01 Marc 12 tablets — — FDA listed —
Diphenhydramine HCl 25mg 25 mg 69168-0002-93 Allegiant 24 tablets — — FDA listed —
Allergy 25 mg 69168-0048-01 Allegiant 100 tablets — — FDA listed —
Sleep Tabs For Nighttime use 25 mg 69168-0247-24 Allegiant 24 tablets — — FDA listed —
Sleep Aid 25 mg 69168-0263-30 Allegiant 30 tablets — — FDA listed —
Allergy Relief 25 mg 69452-0444-31 BIONPHARMA 600 tablets — — FDA listed —
Allergy Relief 25 mgthis 69517-0003-01 HealthLife 100 tablets — — Discontinued —
Nighttime Sleep Aid 25 mg 69517-0004-03 HealthLife 300 tablets — — Discontinued —
Diphenhydramine HCL 25 mg 69618-0025-01 Reliable 100 tablets — — FDA listed —
Sleep-Aid Nighttime 25 mg 69842-0672-51 CVS 365 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0834-51 CVS 365 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0981-08 CVS 200 tablets — — FDA listed —
Benadryl Allergy 25 mg 70264-0024-01 R 2 tablets — — FDA listed —
GOOD REMEDIES Nighttime Sleep Aid Caplets 25 mg 70692-0011-06 Strive 60 tablets — — FDA listed —
GOOD REMEDIES Allergy Relief 25 mg 70692-0022-06 Strive 60 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25mg 25 mg 70692-0148-01 Strive 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 70692-0151-46 Strive 72 tablets — — FDA listed —
Allergy Relief 25 mg 71141-0177-32 Lidl 100 tablets — — FDA listed —
Benadryl 25 mg 71205-0521-06 Proficient 2 tablets — — FDA listed —
Banophen 25 mg 71205-0611-20 Proficient 20 tablets — — FDA listed —
Allergy Relief 25 mg 71679-0106-06 Health 600 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 71679-0110-06 Health 600 tablets — — FDA listed —
Somnitabs 25 mg 72036-0019-02 HARRIS 32 tablets — — FDA listed —
Allergy Relief 25 mg 72036-0090-01 Harris 12 tablets — — FDA listed —
Rest Simply 25 mg 72036-0091-01 Harris 12 tablets — — FDA listed —
Sleep Aid 25 mg 72090-0020-10 Pioneer 100 tablets — — FDA listed —
Allergy Relief 25 mg 72090-0021-60 Pioneer 600 tablets — — FDA listed —
Allergy Relief 25 mg 72090-0029-60 Pioneer 600 tablets — — FDA listed —
Allergy Relief 25 mg 72090-0040-01 Pioneer 1000 tablets — — FDA listed —
basic care allergy relief 25 mg 72288-0479-78 Amazon.com 100 tablets — — FDA listed —
Benadryl Allergy Ultratab 25 mg 73097-0004-02 Savings 2 tablets — — FDA listed —
Diphenhydramine HCl 25 mg/25mg 73376-0003-80 INVAHEALTH 1000 mg — — 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 —
diphenhydramine hydrochloride 25 mg 76457-0002-00 Simpex 100 tablets — — FDA listed —
meijer Allergy Relief 25 mg 79481-0148-04 Meijer, 24 tablets — — FDA listed —
meijer NIGHTTIME Sleep Aid CAPLET 25 mg 79481-0151-01 Meijer, 100 tablets — — FDA listed —
Allergy Relief 25 mg 79903-0056-10 Wal-Mart 100 tablets — — FDA listed —
equate nighttime sleep aid 25 mg 79903-0274-36 WALMART 365 tablets — — FDA listed —
equate allergy relief 25 mg 79903-0297-10 WALMART 100 tablets — — FDA listed —
Allergy Relief 25 mg 79903-0491-10 Walmart 100 tablets — — FDA listed —
Nighttime Sleep-aid 25 mg 80136-0785-96 NORTHEAST 96 tablets — — FDA listed —
Betr sleep aid 25 mg 80267-0431-67 Live 2 tablets — — FDA listed —
Night Time Sleep-Aid 25 mg 80513-0383-22 Advanced 220 tablets — — FDA listed —
Allergy Relief 25 mg 80513-0722-06 Advanced 600 tablets — — FDA listed —
Allergy Relief 25 mg 81522-0109-03 FSA 100 tablets — — FDA listed —
AXIV Allergy Relief 25 mg 82706-0021-02 VIVUNT 100 tablets — — FDA listed —
Allergy Relief 25 mg 82725-1001-01 Cabinet 600 tablets — — FDA listed —
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl 25 mg 82725-1101-01 Cabinet 600 tablets — — FDA listed —
Cabinet Allergy Relief Refill Diphenhydramine HCI 25 mg 82725-3001-02 Cabinet 120 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4001-01 Cabinet 600 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4101-01 Cabinet 600 tablets — — FDA listed —
Goodmeds Allergy Relief 25 mg 82725-4201-01 Cabinet 600 tablets — — FDA listed —
Allergy Relief 25 mg 83059-0021-03 Shield 36 tablets — — FDA listed —
Banophen 25 mg 83112-0555-59 Health 1 tablet — — FDA listed —
Dormmy-Lon 25 mg 83164-0000-01 Haendel 60 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 83939-0683-01 VerityRx 1 tablet — — FDA listed —
Allergy Relief 25 mg 84324-0004-01 NUVICARE 300 tablets — — FDA listed —
Sleep Aid 25 mg 84324-0016-01 NUVICARE 200 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 85766-0092-01 Sportpharm 100 tablets — — FDA listed —
Dr. Simi Allergy Relief 25 mg 85786-0202-24 Farmacias 24 tablets — — FDA listed —
Allergy Relief 25 mg 85828-0048-32 Grocery 100 tablets — — FDA listed —
Allergy Relief 25 mg 87509-0001-06 Famora 650 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$374.3K
Claims incl. refills
20.3K
Beneficiaries
11.2K
Spend / beneficiary
$33.36
Spend / claim
$18.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 ALLERGY RELIEF (this brand).

Top reported reactions

Fatigue19,798
Pain16,932
Headache14,344
Nausea13,604
Rash13,091
Dyspnoea12,903
Diarrhoea11,506

Reporter sex

181,432 reports

Serious outcomes

Death18,453
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,323 9,030
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69517-0003-01 You're viewing this 100 TABLET in 1 BOTTLE (69517-003-01) 2025-09-17 Inactivated by FDA
69517-0003-03 300 TABLET in 1 BOTTLE (69517-003-03) 2025-09-17 Inactivated by FDA
69517-0003-06 600 TABLET in 1 BOTTLE (69517-003-06) 2025-09-17 Inactivated by FDA
69517-0003-10 1000 TABLET in 1 BOTTLE (69517-003-10) 2025-09-17 Inactivated by FDA

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69517-0003-01?
NDC 69517-0003-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 69517-0003-01 and NDC 69517-0003-03?
Both are Allergy Relief Diphenhydramine HCl 25 mg Tablet — the drug itself is identical. NDC 69517-0003-01 is the 100-count package, while NDC 69517-0003-03 is the 300 tablets package.
What NDC number is used to bill for this package of Allergy Relief Diphenhydramine HCl 25 mg Tablet?
Bill NDC 69517-0003-01 — the 11-digit billing format is 69517000301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69517-003-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69517-0003-01, written without dashes as 69517000301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69517-0003-01, the first segment (69517) is the labeler code FDA assigned to HealthLife of USA LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 300 tablets (69517-0003-03), 600 tablets (69517-0003-06), 1000 tablets (69517-0003-10). 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?
HealthLife of USA 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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

Uses: Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

⏱️ Dosage and Administration 41 words ▾

Directions Adults and children 12 years and over: 1 or 2 caplet (s) Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use; Do not take more than 6 caplets a day.

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 9 words ▾

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients: Colloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27, Titanium dioxide.

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69517-0002-05 · HealthLife 69517-0004-03 · HealthLife →
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.