Nighttime Sleep Aid

Product NDC: 41520-034
Requested package NDC: 41520-034-06
11-digit product format: 415200034
Labeler code: 41520
Product ID: 41520-034_dc496e69-0bf8-4215-ac37-4f7256115d90
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Care One (American Sales Company)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-30
Marketing end: 2026-10-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/30mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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: Nighttime Sleep Aid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/30mL

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
1248354	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
bd5de3b3-7cb5-4403-b664-23ac70b9957f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-034-06	Nighttime Sleep Aid	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177		7
41520-034-12	Nighttime Sleep Aid	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-034	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	6	Current NDC, Legacy NDC, 2 package rows	20240306_bd5de3b3-7cb5-4403-b664-23ac70b9957f.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 104 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	3862aaa5-2281-e8f9-e063-6294a90a0f7e	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Sugar Free Cough Suppressant Oral Anesthetic	MENTHOL LOZENGE	McKesson Medical-Surgical	e0dfa6ca-b311-25cb-e053-2a95a90a12cc	2025-09-09	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e648f017-9e30-df6c-e053-2995a90adcd0	2025-09-09	Warnings	Exact identifier application number: M012
Medi-First Honey Lemon Cough Drops	MENTHOL 8.6 MG	Unifirst First Aid Corporation	826e1b87-e5a9-8637-e053-2991aa0aded1	2025-09-09	Warnings	Exact identifier application number: M012
Unishield Cherry Cough	MENTHOL	Unishield	b8297bc1-44b2-3de0-e053-2995a90ad01b	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Cough Supressant	MENTHOL	McKesson Medical-Surgical	db5e0490-2ed8-2d53-e053-2a95a90a98f5	2025-09-09	Warnings	Exact identifier application number: M012
Duratuss AC	CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	3e5ed178-d5d9-b8d4-e063-6394a90a91db	2025-09-09	Warnings	Exact identifier application number: M012
Rompe Pecho CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Efficient Laboratories Inc	96c4dee1-6e66-4442-a7e3-56e874414c17	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	57c458ed-7987-453b-ab24-bbfa6580f920	2025-09-09	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	38637189-d1ee-9405-e063-6394a90ae8b8	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	fd52d8d8-7cd1-4e92-86da-354a1d5213c2	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e8e5fb21-a7fd-44d1-b9c4-83e949699ca6	2025-09-08	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
1248354	diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution	PSN	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-034-06	41520003406	177 mL in 1 BOTTLE, PLASTIC (41520-034-06)	177 ml	2015-06-30	2026-10-30	No	No	Current