Sleep Tabs

Product NDC: 69168-247
11-digit product format: 691680247
Labeler code: 69168
Product ID: 69168-247_51f0777e-6c05-48ee-bb31-a53f18c04627
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Tablets
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-28
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

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: Sleep Tabs
Brand name suffix: For Nighttime use
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
1049630	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
566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	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
69168-247-24	2020-03-13	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts
69168-247-24	2020-01-31	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-247-24	Sleep TabsFor Nighttime use	24 in 1 BOTTLE, UNIT-DOSE	TABLET	24		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-247	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 1 package rows	20231114_566e40b1-e9d7-44e4-b971-eef2b7cf0a7d.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 41 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Allergy	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DOLGENCORP, LLC	b55452e1-25d0-4db5-9621-83f21ec6c298	2026-04-06	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Strategic Sourcing Services LLC	c9fa8d93-d9d6-4206-a13d-32b9e7555e7f	2026-04-02	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	6aaed3fe-ce35-4533-aea4-80096ce8e57a	2026-04-02	Warnings	Exact identifier application number: M012
Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	19879fc8-4962-4c6e-87ed-b874d1d564af	2026-04-01	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Lidl US LLC	7227b330-590b-4731-8a58-e05a0233dd8a	2026-04-01	Warnings	Exact identifier application number: M012
SudoGest	CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	7cd8f7f3-c262-4f7c-bcaf-068be2c952f9	2026-04-01	Warnings	Exact identifier application number: M012
Sanatos Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	4c26be18-733a-e4a8-e063-6294a90a8b02	2026-04-01	Warnings	Exact identifier application number: M012
Sanatos Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	4c26c8bf-0143-ddca-e063-6294a90a3552	2026-04-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Method Pharmaceuticals, LLC	fe126254-6ee6-48c3-965c-96e4276a5314	2026-04-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief	GUAIFENESIN	AmerisourceBergen Drug Corp	200dddd9-e3ff-4cec-a164-d1c9a698f121	2026-03-31	Warnings	Exact identifier application number: M012
Head and Cold	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Hi-Tech Nutraceuticals, LLC	a39c772b-3cce-14cb-e053-2a95a90a733b	2026-03-31	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	44217a8c-7656-a0f6-e063-6294a90af2ad	2026-03-31	Warnings	Exact identifier application number: M012
Dr Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	CalmCo LLC	3f156679-7a91-aff1-e063-6394a90a18f6	2026-03-31	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	A-S Medication Solutions	c26da6e0-ab1c-46c2-acf5-0074958c03cd	2026-03-31	Warnings	Exact identifier application number: M012
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	ba174fcc-da1e-420c-bf9c-179ad65c2848	2026-03-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Amerisource Bergen	8e0c6f8d-559c-45de-9362-1b713fd78a7a	2026-03-30	Warnings	Exact identifier application number: M012
Dr. Simi Daytime Cold and Flu	ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG	Farmacias De Similares TX LLC	4e448fd0-cb6b-b69b-e063-6394a90afde8	2026-03-30	Warnings	Exact identifier application number: M012
Dr. Simi Nighttime Cold and Flu	ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG	Farmacias De Similares TX LLC	4e5772ee-586c-6191-e063-6294a90a132d	2026-03-30	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HCL	HyVee Inc	75b19163-db1c-42fc-8bbb-364be16b9b2f	2026-03-30	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	a9f23c63-eeda-4de9-aec6-fe482f469e98	2026-03-27	Warnings	Exact identifier application number: M012

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
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-247-24	69168024724	24 TABLET in 1 BOTTLE, UNIT-DOSE (69168-247-24)	24 tablet	2015-04-28	0000-00-00	No	No	Current