Somnapure

Product NDC: 69721-005
11-digit product format: 697210005
Labeler code: 69721
Product ID: 69721-005_35de71a0-7e1c-45fb-97d1-ddf485df6e3c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Force Factor Brands LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-20
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

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: Somnapure
Brand name suffix: Clinical Strength
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085945	Internal RxNorm lookup
1609070	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
063517c0-bcb1-46dd-85f1-bbb2f24274ef	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
69721-005-30	2022-02-01	C162847	48780-1	d6a99b39-9a41-a426-e053-dadaa90af4c2	Somnapure Clinical Strength
69721-005-30	2022-01-28	C162847	48780-1	d6a99b39-9a41-a426-e053-dadaa90af4c2	Somnapure Clinical Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69721-005-30	SomnapureClinical Strength	1 in 1 CARTON	TABLET, COATED	1		4
69721-005-30	SomnapureClinical Strength	30 in 1 BOTTLE	TABLET, COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69721-005	SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FORCE FACTOR BRANDS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241210_063517c0-bcb1-46dd-85f1-bbb2f24274ef.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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	40e73317-5126-4961-8f28-60899ffbec5a	2024-02-20	Warnings	Exact identifier application number: M010
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	2424fb95-06e2-49e7-aea0-7797a37aef4d	2024-02-20	Warnings	Exact identifier application number: M010
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	f5b609e1-e63b-2e3b-e053-2995a90a76b9	2024-02-12	Warnings	Exact identifier application number: M010
Kroger Nighttime Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	f0f3f58d-9457-4697-98e6-ef52d350cf67	2024-01-29	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Allegiant Health	88feea1d-c961-45e9-b9a6-1418b970aaba	2024-01-16	Warnings	Exact identifier application number: M010
Sleep-Aid Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	4283558d-62df-4297-bc85-a4e06681a920	2024-01-11	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	d3f35102-94ed-4da0-9c29-312e5468fa05	2023-12-29	Warnings	Exact identifier application number: M010
nighttime sleep-aid	DIPHENHYDRAMINE HCL	Bionpharma Inc.	c0074c77-287e-6c26-e053-2995a90a4d31	2023-12-26	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYRAMINE HYDROCHLORIDE	TARGET CORPORATION	fac83dad-f6fd-3316-e053-6394a90a99aa	2023-12-21	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	fc7ed67f-bac9-f9ed-e053-6294a90ad9a1	2023-12-16	Warnings	Exact identifier application number: M010
Sleep-Aid, Circle K	DIPHENHYDRAMINE HCL CAPLET, 25MG	Lil' Drug Store Products, Inc.	d3ad24c4-44ba-6451-e053-2a95a90a1339	2023-12-14	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	fed2f7ae-2829-f967-e053-6294a90adc0a	2023-10-12	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Better Living Brands LLC	2b730fa5-47f9-468d-86ed-0d49d9cd8dc4	2023-07-06	Warnings	Exact identifier application number: M010
Diphenhydramine HCl 25mg	SLEEP AID	Allegiant Health	2890e4ba-d642-437d-8a86-24996a74e027	2021-11-23	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Allegiant Health	9a0b347e-5719-42f3-9050-df5165495e88	2021-10-14	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Allegiant Health	ec57db48-0f3a-4b12-8633-b45a4366c269	2020-11-06	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
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	Somnapure Clinical Strength 50 MG Oral Tablet	PSN	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	diphenhydramine hydrochloride 50 MG Oral Tablet [Somnapure]	SBD	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	Somnapure 50 MG Oral Tablet	SY	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69721-005-30	69721000530	1 BOTTLE in 1 CARTON (69721-005-30) / 30 TABLET, COATED in 1 BOTTLE	1 bottle	2018-03-20	0000-00-00	No	No	Current