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 70 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Throat Soothing Drops Creamy Strawberry	THROAT SOOTHING CREAMY STRAWBERRY	Cardinal Health 110, LLC. DBA Leader	26cd146a-6461-604f-e063-6394a90ac36e	2025-12-22	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS CREAMY STRAWBERRY	Medical Group Care LLC	043a5e11-30c3-44cd-e063-6394a90a318b	2025-12-22	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS CHERRY	Medical Group Care LLC	29f3f6dd-751e-1dfe-e063-6394a90a0dbb	2025-12-22	Warnings	Exact identifier application number: M012
MGC Cough Drops	MENTHOL	Medical Group Care LLC	437f6b77-ecf8-2cd8-e063-6394a90ad45d	2025-12-22	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS HONEY	Medical Group Care LLC	f4a92a69-e562-1cec-e053-2a95a90a0165	2025-12-22	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS VANILLA HONEY	Medical Group Care LLC	043999bc-3efe-5d29-e063-6294a90a95f4	2025-12-22	Warnings	Exact identifier application number: M012
MGC Health Throat Soothing Drops Creamy Strawberry	PECTIN	Medical Group Care LLC	3fa195b5-0712-aada-e063-6394a90a9069	2025-12-22	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Creamy Strawberry	PECTIN, MENTHOL	Chain Drug Marketing Association, Inc.	18d28b91-55a7-4d0d-8404-4f21afdef989	2025-12-22	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS CHERRY	DISCOUNT DRUG MART	0668492e-c47e-b7cf-e063-6394a90a309b	2025-12-22	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS MENTHOL	DISCOUNT DRUG MART	06574e56-13b8-a3af-e063-6394a90a4867	2025-12-22	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	DISCOUNT DRUG MART	0668ddcc-0214-8e97-e063-6294a90a4f32	2025-12-22	Warnings	Exact identifier application number: M012
caring mill Cough drops CHERRY	MENTHOL	FSA STORE INC.	9d666061-f7a8-4318-8db1-b65373689e1d	2025-12-22	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS CHERRY	Pharmacy Value Alliance LLC	018f4790-8785-94f4-e063-6394a90a1916	2025-12-22	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS HONEY LEMON	Pharmacy Value Alliance LLC	0191fcf7-abc1-e583-e063-6294a90a7854	2025-12-22	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS MENTHOL	Pharmacy Value Alliance LLC	019211bf-dd4b-5f4c-e063-6294a90aacfb	2025-12-22	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS BLACK CHERRY SUGAR FREE	Pharmacy Value Alliance LLC	018f20b1-06e0-eb13-e063-6394a90a5ec5	2025-12-22	Warnings	Exact identifier application number: M012
Quality Choice Cherry Cough Drops	CHERRY COUGH DROPS	Chain Drug Marketing Association, Inc.	6a407092-4b71-4156-b4ad-930782b5fb43	2025-12-22	Warnings	Exact identifier application number: M012
Quality Choice Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Chain Drug Marketing Association, Inc.	1fd09b04-9c79-da20-e063-6394a90ae263	2025-12-22	Warnings	Exact identifier application number: M012
Quality Choice Menthol Cough Drops	MENTHOL COUGH DROPS	Chain Drug Marketing Association, Inc.	3364470e-d9bb-42a6-9bd5-80c0bed8bc9e	2025-12-22	Warnings	Exact identifier application number: M012
Quality Choice Honey Lemon Sugar Free Cough Drops	HONEY LEMON SUGAR FREE COUGH DROPS	Chain Drug Marketing Association, Inc.	1fd0a790-c67c-216f-e063-6294a90ae971	2025-12-22	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