Benadryl

Product NDC
66715-9706
11-digit product format
667159706
Labeler code
66715
Product ID
66715-9706_2783d396-2842-91e9-e063-6294a90a88fe
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-16
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66715-970666715-9706-1DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benadryl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de2a64ce-c169-4162-b79e-d3809bea2147Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9706-1Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-9706-1Benadryl1 in 1 CARTONTABLET, FILM COATED110
66715-9706-2Benadryl2 in 1 CARTONTABLET, FILM COATED210
66715-9706-2Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-9706-3Benadryl3 in 1 CARTONTABLET, FILM COATED310
66715-9706-3Benadryl2 in 1 POUCHTABLET, FILM COATED210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
DiphenhydramineACTIVE MOIETY8GTS82S83MBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
D&C red no. 27INACTIVE INGREDIENT2LRS185U6KBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ABENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9706BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 6 package rows20241123_de2a64ce-c169-4162-b79e-d3809bea2147.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.adb658c8-db8d-4db6-80c8-e0f2de88a2de2026-05-27WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyc71427d4-707f-411f-8bd4-133517a9992b2026-05-26WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCVS PHARMACY, INC643e929d-9e62-4260-91ee-e88a184dd7cd2026-05-26WarningsExact identifier
application number: M012
TopCare Day Time Nite Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCc00ff684-acaf-4fbe-bc74-7e48751b927d2026-05-26WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PEPHENYLEPHRINECabinet Health P.B.C.4e75da23-35f2-431c-92cb-c2c4cb3f09f12026-05-26WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy13492631-d5de-4562-a201-664f7d3591de2026-05-26WarningsExact identifier
application number: M012
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
application number: M012
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsExact identifier
application number: M012
ClorReliefCHLORPHENIRAMINE MALEATEFERRER MEDICAL INNOVATIONS LLCdb729011-f72f-5911-e053-2a95a90a68bf2026-05-22WarningsExact identifier
application number: M012
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSNde2a64ce-c169-4162-b79e-d3809bea214710
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNde2a64ce-c169-4162-b79e-d3809bea214710
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBDde2a64ce-c169-4162-b79e-d3809bea214710
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDde2a64ce-c169-4162-b79e-d3809bea214710
1049632Benadryl 25 MG Oral TabletSYde2a64ce-c169-4162-b79e-d3809bea214710
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSYde2a64ce-c169-4162-b79e-d3809bea214710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9706-1667159706012 in 1 POUCHHistorical
66715-9706-2667159706022 POUCH in 1 CARTON (66715-9706-2) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2018-12-140000-00-00NoNoCurrent
66715-9706-3667159706033 POUCH in 1 CARTON (66715-9706-3) / 2 TABLET, FILM COATED in 1 POUCH3 pouch2018-12-140000-00-00NoNoCurrent