FDA.reportPublic FDA data

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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd5de3b3-7cb5-4403-b664-23ac70b9957fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-034-06Nighttime Sleep Aid177 mL in 1 BOTTLE, PLASTICLIQUID1777
41520-034-12Nighttime Sleep Aid355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-034NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]6Current NDC, Legacy NDC, 2 package rows20240306_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 120 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC131b1f17-cd86-f9b3-e063-6294a90a30282025-02-12WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates, LLC17d0dbc7-c8c2-7917-e063-6394a90a42af2025-02-12WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEKroger Companybc00bbf8-52bb-fa75-e053-2a95a90a94062025-02-11WarningsExact identifier
application number: M012
Daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELSTIME CAP LABORATORIES, INC.fd24653e-c4fa-3c09-e053-6394a90aaa9e2025-02-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELSTIME CAP LABORATORIES INC.fd81dd4b-9617-f4c1-e053-6394a90a5e722025-02-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDOLGENCORP, LLCbe2207b7-b8f8-7fba-e053-2a95a90abd162025-02-10WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEKroger Companybc0115a3-5322-855d-e053-2995a90aba272025-02-10WarningsExact identifier
application number: M012
Day time high blood pressure cold and fluACETAMINOPHEN DEXTROMETHORPHAN HBRCamber Consumer Care09fbd872-0970-4864-9308-4a7b859839202025-02-10WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf05e11ce-c908-acbc-e053-2a95a90a584e2025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf035c499-cda6-fadf-e053-2995a90af4572025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6d977ce-bbca-f1cc-e053-6394a90acc962025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da36d3-496d-2336-e053-6394a90a0f832025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da2e02-42c7-1ede-e053-6394a90aff5f2025-02-09WarningsExact identifier
application number: M012
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
application number: M012
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
application number: M012
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
application number: M012
SofSkin Vaporizing Chest Rub and Cough SuppressantCAMPHOR, MENTHOL, EUCALYPTUS OILViny Health and Beauty Inc34626cf5-64fc-15c0-e063-6294a90aa3102025-02-04WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY, INC17922df7-7867-4300-bd99-55aee7b606062025-02-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healthf4b8ff54-47b5-4d18-bf4e-b101abb22a242025-02-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNbd5de3b3-7cb5-4403-b664-23ac70b9957f7
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDbd5de3b3-7cb5-4403-b664-23ac70b9957f7
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYbd5de3b3-7cb5-4403-b664-23ac70b9957f7
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYbd5de3b3-7cb5-4403-b664-23ac70b9957f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-034-0641520003406177 mL in 1 BOTTLE, PLASTIC (41520-034-06) 177 ml2015-06-302026-10-30NoNoCurrent
41520-034-1241520003412355 mL in 1 BOTTLE, PLASTIC (41520-034-12) 355 ml2015-06-302026-10-30NoNoCurrent