Sleep Aid

Product NDC: 69168-263
11-digit product format: 691680263
Labeler code: 69168
Product ID: 69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl 25 mg
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-03
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 Aid
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
dbbc535f-515a-4d9b-b799-34e60f5230bb	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
69168-263-30	2020-03-13	Drug Facts
69168-263-93	2020-03-13	Drug Facts
69168-263-30	2020-01-31	Drug Facts
69168-263-93	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-263-30	Sleep Aid	30 in 1 BOTTLE	TABLET	30	7
69168-263-54	Sleep Aid	1 in 1 CARTON	TABLET	1	7
69168-263-54	Sleep Aid	16458 in 1 BAG	TABLET	16458	7
69168-263-93	Sleep Aid	24 in 1 BOX	TABLET	24	7
69168-263-98	Sleep Aid	200 in 1 BOTTLE	TABLET	200	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-263	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	7	Current NDC, Legacy NDC, 5 package rows	20250515_dbbc535f-515a-4d9b-b799-34e60f5230bb.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 173 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Akin	GUAIFENESIN	Southern Sales & Service, Inc.	bb2c9f21-6765-4286-bd71-de01cdf4c4e9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM	DEXTROMETHORPHAN, GUAIFENESIN	Southern Sales & Service, Inc.	1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a	2023-11-29	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	Warnings	Exact identifier application number: M012
SIMPEX Guaifenesin	GUAIFENESIN	Simpex Pharma Pvt. Ltd	1594f9d6-0c48-42bf-b76b-d621f215179a	2023-11-29	Warnings	Exact identifier application number: M012
Stona	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	8b89f50d-88f8-4773-92ea-5ada61766056	2023-11-28	Warnings	Exact identifier application number: M012
Stona	DEXTROMETHORPHAN HYDROBROMIDE	Sato Pharmaceutical Co., Ltd.	1ccc9e56-32a4-450f-8412-5814b6aef285	2023-11-28	Warnings	Exact identifier application number: M012
Neo-Synephrine Maximum	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab8682a4-1f66-6709-e053-2995a90a8b4a	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Regular	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab860c10-b8cf-3f92-e053-2a95a90a7317	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Mild	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	9b8e9162-e4da-14d9-e053-2995a90a2269	2023-11-16	Warnings	Exact identifier application number: M012
Universal Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS	Universal Distribution Center LLC	b1d25572-da21-408d-aab3-3a0741dfff12	2023-11-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Severe, Caseys 4goog	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	0334259d-587e-b2d5-e063-6394a90a3e56	2023-11-14	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Sato Pharmaceutical Co., Ltd.	0b638db4-5ed3-4665-abcd-f95e677adbd8	2023-11-12	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	6c90b415-4c5f-49e5-beb6-4cf225797b21	2023-11-06	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	8b8582c0-8aef-482f-9738-2f1d4e325d64	2023-11-06	Warnings	Exact identifier application number: M012
Cold and Flu Severe Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	27ade5f8-2003-4dc6-9244-42676791e1f8	2023-11-06	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	ec2070df-8a8a-4cd1-8830-62655433fb3b	2023-11-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	093eed84-79b1-7914-e063-6394a90a37af	2023-11-03	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff68377-2273-6c6c-e053-2995a90a36b2	2023-11-03	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	096bbcaa-fce1-0fc2-e063-6294a90ad597	2023-11-03	Warnings	Exact identifier application number: M012
TopCare Nite Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	adc8edf5-ebbe-4d94-9018-aa0dbe118112	2023-11-03	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	dbbc535f-515a-4d9b-b799-34e60f5230bb	7
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	dbbc535f-515a-4d9b-b799-34e60f5230bb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-263-30	69168026330	30 TABLET in 1 BOTTLE (69168-263-30)	30 tablet	2015-03-03	0000-00-00	No	No	Current
69168-263-54	69168026354	1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG	1 bag	2025-05-08		No	No	Current
69168-263-93	69168026393	24 TABLET in 1 BOX (69168-263-93)	24 tablet	2015-03-03	0000-00-00	No	No	Current
69168-263-98	69168026398	200 TABLET in 1 BOTTLE (69168-263-98)	200 tablet	2021-07-23	0000-00-00	No	No	Current