BENALDRYL

Product NDC: 42787-104
11-digit product format: 427870104
Labeler code: 42787
Product ID: 42787-104_6854488c-af16-4d30-9a24-bcf3aafac41e
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HCL
Dosage form: TABLET
Route: ORAL
Labeler: AJES PHARMACEUTICALS,LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-09-01
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/250mg
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42787-104		I	Inactivated by FDA	2026-10-12
excluded product	product	42787-104		I	Inactivated by FDA	2026-10-12
excluded package	package	42787-104	42787-104-30	I	Inactivated by FDA	2026-10-12
excluded package	package	42787-104	42787-104-12	I	Inactivated by FDA	2026-10-12

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42787-104-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42787-104-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42787-104-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42787-104-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42787-104-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42787-104-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42787-104-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42787-104-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42787-104-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42787-104-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42787-104-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42787-104-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42787-104-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42787-104-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42787-104-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42787-104-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42787-104-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42787-104-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42787-104-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42787-104-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42787-104-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42787-104-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42787-104-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42787-104-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42787-104-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42787-104-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42787-104-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42787-104-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42787-104-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42787-104-12	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42787-104-12	2020-01-31	C162847	48780-1	9d75b9d0-a8ca-f424-e053-dadaa90a57ce	Drug Facts
42787-104-30	2020-01-31	C162847	48780-1	9d75b9d0-0f43-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42787-104-30	BENALDRYL	1 in 1 CARTON	TABLET	1	4
42787-104-30	BENALDRYL	1250 mg in 1 BOTTLE, PLASTIC	TABLET	1250	4
42787-104-12	BENALDRYL	1 in 1 CARTON	TABLET	1	1
42787-104-12	BENALDRYL	25000 mg in 1 BOTTLE, PLASTIC	TABLET	25000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42787-104	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	4	Legacy NDC, 2 package rows	20121026_db1ed7d7-5203-4bc6-8043-0594c2e49efc.zip
42787-104	BENALDRYL (DIPHENHYDRAMINE HCL ) TABLET [AJES PHARMACEUTICALS,LLC]	1	Legacy NDC, 2 package rows	20140526_a5df4f25-fa80-49ac-922d-60a6d1abe8d5.zip

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
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	db1ed7d7-5203-4bc6-8043-0594c2e49efc	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	db1ed7d7-5203-4bc6-8043-0594c2e49efc	4
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a5df4f25-fa80-49ac-922d-60a6d1abe8d5	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a5df4f25-fa80-49ac-922d-60a6d1abe8d5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42787-104-12	42787010412	1 in 1 CARTON	Historical
42787-104-30	42787010430	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	AJES PHARMACEUTICALS,LLC	2014-05-25	HUMAN OTC DRUG LABEL	1
Drug Facts	AJES PHARMACEUTICALS,LLC	2012-10-24	HUMAN OTC DRUG LABEL	4