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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66715-9706	66715-9706-1	D	Discontinued by firm		2026-10-16

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
de2a64ce-c169-4162-b79e-d3809bea2147	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66715-9706-1	Benadryl	2 in 1 POUCH	TABLET, FILM COATED	2	10
66715-9706-1	Benadryl	1 in 1 CARTON	TABLET, FILM COATED	1	10
66715-9706-2	Benadryl	2 in 1 CARTON	TABLET, FILM COATED	2	10
66715-9706-2	Benadryl	2 in 1 POUCH	TABLET, FILM COATED	2	10
66715-9706-3	Benadryl	3 in 1 CARTON	TABLET, FILM COATED	3	10
66715-9706-3	Benadryl	2 in 1 POUCH	TABLET, FILM COATED	2	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
D&C red no. 27	INACTIVE INGREDIENT	2LRS185U6K	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-9706	BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Current NDC, Legacy NDC, 6 package rows	20241123_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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	50762d7c-5efd-4f83-e063-6294a90abf7f	2026-04-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	6427b418-89d1-4eac-b25b-0adfefc204fc	2026-04-27	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier application number: M012
Leader Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	333c7042-95b8-4d98-9df1-4287017afa36	2026-04-25	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f2d55d1b-c3d4-4c35-b761-681ed50273bd	2026-04-24	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Sportpharm LLC	2c4e0d5e-958d-4274-876a-52126c795c0f	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50364a42-3333-51fe-e063-6394a90ab71e	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5036dc50-e95b-ea8d-e063-6394a90a6cfe	2026-04-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dcb33d5f-87fa-4043-9b6d-36adec96796c	2026-04-24	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Cardinal Health 107, LLC	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	2026-04-23	Warnings	Exact identifier application number: M012
nitetime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	c5535aaf-c029-48d8-97d1-105a49b5fd95	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	50228b3c-d54a-485d-e063-6394a90a4403	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5025a333-6378-bf59-e063-6394a90af4f0	2026-04-23	Warnings	Exact identifier application number: M012
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	POLY PHARMACEUTICALS, INC.	5025c99f-b946-e2e0-e063-6394a90a13fb	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5026611c-93e7-8f90-e063-6394a90a7baa	2026-04-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	COSTCO WHOLESALE CORPORATION	5180abbc-c6c4-4b82-b6e7-4504e3bcff0f	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	4f963491-e1f0-494d-acb6-5f4d2b267d4a	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	f4b01827-7444-3bfc-e053-2a95a90aebed	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	cfd43b8f-8064-6b88-e053-2a95a90a329e	2026-04-22	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049632	Benadryl 25 MG Oral Tablet	PSN	de2a64ce-c169-4162-b79e-d3809bea2147	10
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	de2a64ce-c169-4162-b79e-d3809bea2147	10
1049632	diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]	SBD	de2a64ce-c169-4162-b79e-d3809bea2147	10
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	de2a64ce-c169-4162-b79e-d3809bea2147	10
1049632	Benadryl 25 MG Oral Tablet	SY	de2a64ce-c169-4162-b79e-d3809bea2147	10
1049632	Benadryl Allergy Ultratab 25 MG Oral Tablet	SY	de2a64ce-c169-4162-b79e-d3809bea2147	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66715-9706-1	66715970601	2 in 1 POUCH						Historical
66715-9706-2	66715970602	2 POUCH in 1 CARTON (66715-9706-2) / 2 TABLET, FILM COATED in 1 POUCH	2 pouch	2018-12-14	0000-00-00	No	No	Current
66715-9706-3	66715970603	3 POUCH in 1 CARTON (66715-9706-3) / 2 TABLET, FILM COATED in 1 POUCH	3 pouch	2018-12-14	0000-00-00	No	No	Current