Banophen

Product NDC: 0904-5307
11-digit product format: 009045307
Labeler code: 0904
Product ID: 0904-5307_4b4333df-2739-654b-e063-6394a90a4a1d
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hcl
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-11-02
Marketing end: 2028-01-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-5307		D	Discontinued by firm	2026-10-23
excluded package	package	0904-5307	0904-5307-60	D	Discontinued by firm	2026-10-23
excluded package	package	0904-5307	0904-5307-80	D	Discontinued by firm	2026-10-23

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 · 36 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 package	package	0904-5307-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5307-60	`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 package	package	0904-5307-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5307-60	`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: Banophen

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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
1020477	Internal RxNorm lookup
1020479	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
7f2b72cc-d4f7-431f-be61-c103cf8c489e	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	Strength	SPL version
0904-5307-60	Banophen	100 in 1 BOTTLE	CAPSULE	100		10
0904-5307-80	Banophen	1000 in 1 BOTTLE	CAPSULE	1000		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5307-60	EA - Each	0904-5307	fbc100c3-1d2e-4360-bd2f-a92b1e556d3b	1	2013-02-11
0904-5307-80	EA - Each	0904-5307	602b6862-e0e7-4d9b-bcb4-48a7a3eba316	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5307	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20240214_7f2b72cc-d4f7-431f-be61-c103cf8c489e.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 173 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORP	0b1e230d-4354-bf61-e063-6394a90a2b2f	2023-12-09	Warnings	Exact identifier application number: M012
Phenylephrine HCl Maximum Strength	PHENYLEPHRINE HCL	A-S Medication Solutions	fcb769d0-aa45-48eb-acd0-2247b392f9fe	2023-12-09	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf915af-a016-0a46-e063-6394a90aacf5	2023-12-08	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and Flu	DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI	TARGET Corporation	0bf9c0df-7676-3060-e063-6394a90a16c7	2023-12-08	Warnings	Exact identifier application number: M012
Nazal	NAPHAZOLINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	4d4043f8-5ed3-4027-beb6-687db1308202	2023-12-06	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	8b4557d4-74a0-400f-ad7a-6d31473b3c67	2023-12-06	Warnings	Exact identifier application number: M012
Childrens Plus Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1598e6f8-08ee-4216-a5ab-76cad37b09a7	2023-12-06	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf	2023-12-05	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash Relief	PETROLATUM, ZINC OXIDE	Welmedix LLC	551e6cce-7adc-4e98-baff-2703b83d7526	2023-12-05	Warnings	Exact identifier application number: M012
Stona-S	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1	2023-12-04	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	afc95c82-18da-487b-b4bb-51e0be0378da	2023-12-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	a14643a1-3d91-491a-88d6-22dccde97938	2023-12-04	Warnings	Exact identifier application number: M012
TopCare Day Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	14d53907-a4a2-4a0f-b2d6-33474945f9e1	2023-12-04	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Proficient Rx LP	62934d0f-b23d-4c03-9d60-a7bad41f9b42	2023-12-01	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	b1c849e5-8003-4fd3-811d-6a927523e353	2023-12-01	Warnings	Exact identifier application number: M012
Akin Expectorant Formula Strawberry Banana	GUAIFENESIN	Southern Sales & Service, Inc.	b63b0133-d2da-432b-a154-9e77535bbef9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM Strawberry Banana	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Southern Sales & Service, Inc.	7a81efd8-775d-455e-860f-f3e3b369a0a7	2023-11-29	Warnings	Exact identifier application number: M012
Akin	GUAIFENESIN	Southern Sales & Service, Inc.	bb2c9f21-6765-4286-bd71-de01cdf4c4e9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM	DEXTROMETHORPHAN, GUAIFENESIN	Southern Sales & Service, Inc.	1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a	2023-11-29	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	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
1020479	BANOPHEN 50 MG Oral Capsule	PSN	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020479	Banophen 50 MG Oral Capsule	SY	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	d0f4b9f4-e727-4d47-b156-7bcdcb1606da	106
1020479	BANOPHEN 50 MG Oral Capsule	PSN	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020479	Banophen 50 MG Oral Capsule	SY	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	11
1020479	BANOPHEN 50 MG Oral Capsule	PSN	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020479	Banophen 50 MG Oral Capsule	SY	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	7f2b72cc-d4f7-431f-be61-c103cf8c489e	10
1020479	BANOPHEN 50 MG Oral Capsule	PSN	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020479	Banophen 50 MG Oral Capsule	SY	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	0e06dca9-485a-4367-bcfa-07e0cc27c128	7
1020479	BANOPHEN 50 MG Oral Capsule	PSN	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020479	Banophen 50 MG Oral Capsule	SY	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	0f52270a-b11a-4fa1-aac2-9fe5ff625419	5
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	ea0c7005-3122-4ff4-8bc1-dda8116803c1	4
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	ea0c7005-3122-4ff4-8bc1-dda8116803c1	4
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	ea0c7005-3122-4ff4-8bc1-dda8116803c1	4
1020479	BANOPHEN 50 MG Oral Capsule	PSN	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1020479	Banophen 50 MG Oral Capsule	SY	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	d4ec6dfd-61b0-7153-e053-2995a90ad88f	2
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	1d026ead-c3de-4dc6-9d3c-5a603f6dde4e	1
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	1d026ead-c3de-4dc6-9d3c-5a603f6dde4e	1
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	1e01f8b8-ca29-902e-e063-6394a90a4cb8	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	1d026ead-c3de-4dc6-9d3c-5a603f6dde4e	1
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	1d026ead-c3de-4dc6-9d3c-5a603f6dde4e	1
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	1e01f8b8-ca29-902e-e063-6394a90a4cb8	1
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	1d026ead-c3de-4dc6-9d3c-5a603f6dde4e	1
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	1e01f8b8-ca29-902e-e063-6394a90a4cb8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5307-60	00904530760	100 CAPSULE in 1 BOTTLE (0904-5307-60)	100 capsule	2009-11-02	2028-01-31	No	No	Current
0904-5307-80	00904530780	1000 CAPSULE in 1 BOTTLE (0904-5307-80)	1000 capsule	2009-11-02	2028-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0836-Major(100C/1000C)	Bryant Ranch Prepack	2026-05-18	HUMAN OTC DRUG LABEL	11
0836-Major(100C/1000C)	Bryant Ranch Prepack	2026-04-24	HUMAN OTC DRUG LABEL	106
0836-Major(100C/1000C)	Preferred Pharmaceuticals Inc.	2026-04-06	HUMAN OTC DRUG LABEL	5
0836-Major(100C/1000C)	Major Pharmaceuticals	2026-02-20	HUMAN OTC DRUG LABEL	10
Diphenhydramine HCL	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN OTC DRUG LABEL	15
0836-Major(100C/1000C)	NuCare Pharmaceuticals,Inc.	2024-12-12	HUMAN OTC DRUG LABEL	2
0836-Major(100C/1000C)	NuCare Pharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc	2024-07-24	HUMAN OTC DRUG LABEL	1
0836-Major(100C/1000C)	REMEDYREPACK INC.	2022-09-16	HUMAN OTC DRUG LABEL	9
0836-Major(100C/1000C)	REMEDYREPACK INC.	2022-09-14	HUMAN OTC DRUG LABEL	7
Banophen	Lake Erie Medical DBA Quality Care Products LLC	2021-05-17	HUMAN OTC DRUG LABEL	5557
Banophen	Unit Dose Services	2017-11-07	HUMAN OTC DRUG LABEL	7
Diphendydramine Hydrochloride Capsules	NCS HealthCare of KY, Inc dba Vangard Labs	2013-05-07	HUMAN OTC DRUG LABEL	8
Diphenhydramine Hydrochloride Capsules	H.J. Harkins Company, Inc.	2012-04-18	HUMAN OTC DRUG LABEL	4
Diphendydramine Hydrochloride Capsules	Contract Pharmacy Services-PA	2010-07-30	HUMAN OTC DRUG LABEL	1