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 firm2026-10-27

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 123 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
application number: M012
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsExact identifier
application number: M012
AVON HeXashield Congestion Relief OriginalOXYMETAZOLINE HYDROCHLORIDETai Guk Pharm. Co., Ltd.8f2c152c-c564-0cba-e053-2a95a90ab3c72025-01-01WarningsExact identifier
application number: M012
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice57a44bbf-a304-47b9-8adc-4442c77878532025-01-01WarningsExact identifier
application number: M012
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsExact identifier
application number: M012
Adult Tussin DM Lil Drug Store ProductsDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINLil' Drug Store Products, Inc1915cf2a-ebaa-4c47-8991-5b741fa01be22024-12-31WarningsExact identifier
application number: M012
Congestion Relief Lil Drug Store ProductsOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc8fca348c-ecb6-4a91-89dd-8bd4c05ac7452024-12-31WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb2024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Congestion GrapeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH9576723b-748c-45e7-bc0d-cc109b9f67352024-12-30WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store Products, Inc.ef6836fa-d104-d7b3-e053-2a95a90af2b82024-12-30WarningsExact identifier
application number: M012
Circle K Congestion ReliefOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc7e02fe57-f42f-4d3c-9002-4c4c0b1fafd62024-12-30WarningsExact 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