Nighttime Sleep Aid

Product NDC: 41520-034
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 80 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cherry throat relief lozenges	BENZOCAINE	Cintas Corporation	49b25e9e-1d47-4a10-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
cherry sore throat lozenge	BENZOCAINE	CVS Pharmacy	3c54974d-9d15-2fa1-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
honey lemon sore throat lozenges	BENZOCAINE	CVS Pharmacy	3c55009c-4b3e-135e-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	CVS Pharmacy	3bdd24a8-3b44-00cd-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	CVS Pharmacy	3c125b3a-e58f-5c06-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
CVS Menthol Cough Drops	MENTHOL	CVS Pharmacy	de97d13b-bb67-d0e6-e053-2995a90aeb2c	2025-12-07	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	American Sales	34dd34d1-1a08-3470-e054-00144ff8d46c	2025-12-06	Warnings	Exact identifier application number: M012
DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	a79b5541-864b-412a-a085-96986ed6af59	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	346f32cb-74cb-4896-b770-76d5f829a17d	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	530b2d27-5883-489e-87fa-90b45eb93b3c	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ee666963-e686-4374-b52b-a677f1cd4114	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No-Drip Allergy Sinus	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	3beb5839-7422-449d-e054-00144ff88e88	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Nighttime Multi-Symptom Cold	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	513ca24f-1262-4a2d-e054-00144ff8d46c	2025-12-05	Warnings	Exact identifier application number: M012
Afrin Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	a49a506e-aca2-4af0-a50b-dca2c031e61d	2025-12-05	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	a746cef4-1fb4-45cf-e053-2995a90a02c8	2025-12-05	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Health Pharma USA LLC	31755594-3e1c-b290-e063-6394a90aba61	2025-12-05	Warnings	Exact identifier application number: M012
Tabcin Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,	Pharmadel LLC	0670c33e-8a3c-ae00-e063-6294a90a165b	2025-12-05	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	d0dd4a75-da65-4c66-b65f-54ee14100846	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care Cherry Cough Drops	MENTHOL	Amazon.com	c0588221-0c84-66d8-e053-2995a90a874f	2025-12-05	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
41520-034-12	41520003412	355 mL in 1 BOTTLE, PLASTIC (41520-034-12)	355 ml	2015-06-30	2026-10-30	No	No	Current