Pharbedryl

Product NDC: 16103-348
Requested package NDC: 16103-348-03
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 · 3 matching rows.

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

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

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 1 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	d66b1a2e-49b6-473b-acec-2694c73ce8b4	2026-08-19	Warnings	Exact identifier application number: M010
CVS Childrens Nighttime Multi Symptom Cold	ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	2026-08-19	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	a575a914-14a0-442c-a504-ac7a0aa0ac77	2026-08-18	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	e8785ba8-e53e-491e-bbfe-04e860f36131	2026-08-18	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	9f944edc-a317-4967-ae54-67b5d183591b	2026-08-18	Warnings	Exact identifier application number: M010
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	4b6fc81e-e3ba-4a36-834c-82766311aa73	2026-08-17	Warnings	Exact identifier application number: M010
CVS Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	CVS PHARMACY	333e170e-52cd-4218-8d15-0bf3c5c75cb9	2026-08-14	Warnings	Exact identifier application number: M010
CVS NightTime Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	0f0cc40d-7939-4d4d-a931-b4de4070fea1	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	8db277e2-9d98-40b6-8000-a51c57fb4ece	2026-08-14	Warnings	Exact identifier application number: M010
Theraflu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	4b567234-1da9-4e10-a427-877eea2be1c1	2026-08-14	Warnings	Exact identifier application number: M010
CVS Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	6fb6cfde-30a6-419c-973d-8abdc72611ed	2026-08-07	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	2bb3016a-2e03-43fe-a655-45d4ec872c79	2026-08-05	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Alcohol Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	6e398d21-6cfa-4f9b-9219-0cd949e88266	2026-08-05	Warnings	Exact identifier application number: M010
Sleep Tabs	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	ff8b7346-5be5-4e76-9ee2-d52fab66f6c5	2026-08-03	Warnings	Exact identifier application number: M010
Mantra	MANTRA SLEEP AID WILD CHERRY	MOREMED INC.	316d11fe-a173-a1dd-e063-6394a90af499	2026-07-27	Warnings	Exact identifier application number: M010
Wal Som Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ff475a69-dbb2-40a9-b7f4-9c7b7e975d19	2026-07-23	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	TARGET Corporation	336ac29d-db24-44da-a299-5a4793ae8f6a	2026-07-21	Warnings	Exact identifier application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	9bf2d698-8394-46c3-b7a9-e99ab6bb88e4	2026-07-17	Warnings	Exact identifier application number: M010
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	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	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

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