Pharbedryl

Product NDC: 16103-348
11-digit product format: 161030348
Labeler code: 16103
Product ID: 16103-348_1c298805-036e-4cd1-87cc-1d2e413043b8
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-02-01
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

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-348-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-348-08	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-348-11	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-348-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-348-08	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-348-11	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-348-11	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-348-08	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-348-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Pharbedryl
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049909	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
070e556b-e083-452f-8a7c-aca92470dd61	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-348-03	2023-06-13	Drug Facts
16103-348-08	2023-06-13	Drug Facts
16103-348-11	2023-06-13	Drug Facts
16103-348-03	2023-01-30	Drug Facts
16103-348-08	2023-01-30	Drug Facts
16103-348-11	2023-01-30	Drug Facts
16103-348-03	2021-03-30	Drug Facts
16103-348-08	2021-03-30	Drug Facts
16103-348-11	2021-03-30	Drug Facts
16103-348-03	2020-01-31	Drug Facts
16103-348-08	2020-01-31	Drug Facts
16103-348-11	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-348-08	Pharbedryl	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	5
16103-348-08	Pharbedryl	1 in 1 CARTON	CAPSULE	1	5
16103-348-11	Pharbedryl	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-348-03	EA - Each	16103-348	5de1d9de-7e1e-4271-80c4-090cadb9fcd8	1	2012-07-24
16103-348-08	EA - Each	16103-348	90cd3e96-3e7f-40bb-a237-08d4664982ea	1	2014-12-01
16103-348-11	EA - Each	16103-348	3310a6e3-4317-40ac-a106-9f7606a265f7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-348	PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250101_070e556b-e083-452f-8a7c-aca92470dd61.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 9 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d64f5c2-dfa9-e5f5-e063-6294a90a0711	2025-03-19	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	Harris Teeter, LLC	322a71bb-fc68-4a03-8a24-20cbdbe6d91b	2025-03-13	Warnings	Exact identifier application number: M010
REVASOL SLEEP AID	DIPHENHYDRAMINE HCL	Rnv LLC	30131010-be70-c940-e063-6394a90a190a	2025-03-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	1a7189ba-2d52-44fc-83a4-b9f6156c62ff	2025-03-07	Warnings	Exact identifier application number: M010
meijer NIGHTTIME Sleep Aid SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bede4cd-bf55-8b84-e063-6394a90aa5c9	2025-02-19	Warnings	Exact identifier application number: M010
PHARBEDRYL	DIPHENHYDRAMINE HCL 50MG	Ulai Health LLC	135293fb-5674-4638-be55-b968cf51257e	2025-01-20	Warnings	Exact identifier application number: M010
Allergy Relief 25 mg	DIPHENHYDRAMINE HCL 25MG	Ulai Health LLC	751f13d4-c4d6-47a5-b40d-1563de08c048	2025-01-12	Warnings	Exact identifier application number: M010
RoboCough	DEXTROMETHORPHAN HBR	DXM Pharmacuetical, Inc.	32fa7a09-8624-44c1-b9e4-8a8f0594292b	2025-01-10	Warnings	Exact identifier application number: M010
SleepAid (Diphenhydramine HCL)	DIPHENHYDRAMINE HCL	APNAR PHARMA LP	faaf5d51-d81d-3acc-e053-6294a90ae08f	2025-01-09	Warnings	Exact identifier application number: M010
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	971515fa-b4d2-1197-e053-2995a90a838d	2025-01-03	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	8b0fa259-6702-4667-bac6-f7d0b0839ae0	2025-01-01	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	9f1c078d-e537-4ec0-8ae9-54c98282be29	2024-12-31	Warnings	Exact identifier application number: M010
Discount Drugmart Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Discount Drug Mart, Inc	d6d77c2e-42b3-48f0-a662-3872155ef34d	2024-12-18	Warnings	Exact identifier application number: M010
Kroger Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	THE KROGER CO	98437a72-1b98-4301-b92f-0c17b305cf59	2024-12-18	Warnings	Exact identifier application number: M010
equate nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	6e162152-b414-470c-b146-649d99870577	2024-12-17	Warnings	Exact identifier application number: M010
Quality Choice Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	e8b2858b-a737-c500-e053-2995a90adba6	2024-12-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	f99cc210-b946-42a2-9164-8aa5308c5418	2024-12-11	Warnings	Exact identifier application number: M010
CalmCo Sleep Aid Gummy Bite	DIPHENHYDRAMINE HCL	CalmCo LLC	0c534cbd-40e6-8af0-e063-6394a90a5605	2024-12-07	Warnings	Exact identifier application number: M010
Somnapure Clinical Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Force Factor Brands LLC	063517c0-bcb1-46dd-85f1-bbb2f24274ef	2024-12-06	Warnings	Exact identifier application number: M010
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	c280cf02-ebb2-4847-a66d-d02aff3ea0c9	2024-12-02	Warnings	Exact identifier application number: M010

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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	1ee41c86-6767-43ca-a5bb-fc685fa662cd	13
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	1ee41c86-6767-43ca-a5bb-fc685fa662cd	13
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	070e556b-e083-452f-8a7c-aca92470dd61	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	070e556b-e083-452f-8a7c-aca92470dd61	5
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3ef18965-bafb-cc19-e063-6394a90af17d	2
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3ef18965-bafb-cc19-e063-6394a90af17d	2
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	58ec2d97-168b-505a-e053-2991aa0a3978	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	58ec2d97-168b-505a-e053-2991aa0a3978	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-348-03	16103034803	1 BOTTLE, PLASTIC in 1 CARTON (16103-348-03) > 24 CAPSULE in 1 BOTTLE, PLASTIC		2016-02-01	0000-00-00	No	No	Current
16103-348-08	16103034808	1 BOTTLE, PLASTIC in 1 CARTON (16103-348-08) / 100 CAPSULE in 1 BOTTLE, PLASTIC		2016-02-01	0000-00-00	No	No	Current
16103-348-11	16103034811	1000 CAPSULE in 1 BOTTLE, PLASTIC (16103-348-11)	1000 capsule	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	St. Mary's Medical Park Pharmacy	2026-06-29	HUMAN OTC DRUG LABEL	3
Drug Facts	Pharbest Pharmaceuticals, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	5
Drug Facts	PD-Rx Pharmaceuticals, Inc.	2025-03-20	HUMAN OTC DRUG LABEL	13
Drug Facts	A-S Medication Solutions	2022-09-12	HUMAN OTC DRUG LABEL	15
Drug Facts	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-08	HUMAN OTC DRUG LABEL	1
Diphenhydramine 25 mg Capsule #30 007 Drug Facts	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-11	HUMAN OTC DRUG LABEL	1