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 3 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	2d63400b-43ae-4dd2-b917-3f65e02366b4	2026-06-08	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	TOPCO ASSOCIATES LLC	9558cc42-d27d-42af-b0a7-44cad025165d	2026-05-21	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	dac2a0b9-f851-467b-a39f-3560d42c96e2	2026-05-20	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Walgreen Company	ec3618dd-8713-4f3c-b639-fc240021c7be	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	fbedb50d-b96f-4ce4-a1dc-d2b357cf6de1	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS Pharmacy	0be4ef9a-2484-41dd-8bb8-e92d411f1384	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	ca052b38-de38-7bf0-e053-2995a90a4e85	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	e68d96c8-21c5-406c-b22c-3e384027c79f	2026-05-07	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Kroger Company	b71bb567-5605-430b-b3fa-048fe9bbe8ff	2026-05-04	Warnings	Exact identifier application number: M010
Sleep II Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	ed864c84-a430-4ca8-87e8-04f1c1df538b	2026-05-04	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	f8f17615-e4ec-49d4-9c0d-581d0fd6feb7	2026-04-28	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	888dc258-d5a3-4b62-aea1-c81ea29ff6f5	2026-04-28	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Amerisource Bergen	8f1cb631-4633-4ef5-868e-48a46ab311a4	2026-04-27	Warnings	Exact identifier application number: M010
VICKS ZzzQuil NIGHTTIME SLEEP-AID	DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	05f77c69-c8ea-f8ba-e063-6394a90aa60f	2026-04-23	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Night Pain	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	f3bb75e8-3d43-f91e-e053-2a95a90a584d	2026-04-23	Warnings	Exact identifier application number: M010
Nightime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC.	202bb1ff-3273-4872-e063-6294a90abebb	2026-04-11	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	1be2f00b-5bdd-82e7-e063-6394a90ab9a5	2026-04-06	Warnings	Exact identifier application number: M010
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	HyVee Inc	cf94fa56-01a5-4d6c-ad08-38b0ea363399	2026-04-03	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	84ec323d-0523-41e8-856c-e02d6afdc9ec	2026-04-02	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
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