Diphenhydramine Hydrochloride

Product NDC: 70692-785
11-digit product format: 706920785
Labeler code: 70692
Product ID: 70692-785_aa185f21-9410-4918-b9e5-27f7891578b0
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strive Pharmaceuticals Inc.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-20
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 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 · 16 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	Archive	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70692-785-61	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70692-785-61	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	70692-785-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenhydramine Hydrochloride
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020477	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
971515fa-b4d2-1197-e053-2995a90a838d	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70692-785-61	2022-04-12	C162847	48780-1	d6a99b39-b3e1-a426-e053-dadaa90af4c2	Nighttime Sleep-Aid Diphenhydramine HCl 50mg (Blue Softgel)
70692-785-61	2022-01-28	C162847	48780-1	d6a99b39-b3e1-a426-e053-dadaa90af4c2	Nighttime Sleep-Aid Diphenhydramine HCl 50mg (Blue Softgel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70692-785-15	Diphenhydramine Hydrochloride	150 in 1 BOTTLE	CAPSULE, LIQUID FILLED	150	5
70692-785-61	Diphenhydramine Hydrochloride	16 in 1 BOTTLE	CAPSULE, LIQUID FILLED	16	5
70692-785-71	Diphenhydramine Hydrochloride	275 in 1 BOTTLE	CAPSULE, LIQUID FILLED	275	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70692-785	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250112_971515fa-b4d2-1197-e053-2995a90a838d.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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	971515fa-b4d2-1197-e053-2995a90a838d	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	971515fa-b4d2-1197-e053-2995a90a838d	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	971515fa-b4d2-1197-e053-2995a90a838d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70692-785-15	70692078515	150 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-785-15)	2023-08-01		No	No	Current
70692-785-61	70692078561	16 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-785-61)	2019-08-20	0000-00-00	No	No	Current
70692-785-71	70692078571	275 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-785-71)	2021-12-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nighttime Sleep-Aid Diphenhydramine HCl 50mg (Blue Softgel)	Strive Pharmaceuticals Inc.	2025-01-03	HUMAN OTC DRUG LABEL	5