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		2026-10-15

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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	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