FDA.reportPublic FDA data

Night Time Sleep Aid

Product NDC
55910-114
11-digit product format
559100114
Labeler code
55910
Product ID
55910-114_b2aea145-855c-4ee9-b5e8-b0e209d533b4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Night Time Sleep Aid
Listing expiration
2027-12-31

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
1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-114-12Night Time Sleep Aid355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-114NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]7Current NDC, Legacy NDC, 1 package rows20240724_1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9.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 91 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
application number: M012
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1f3eeb6c-4c44-4e2a-ad72-12c95e6589c97
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1f3eeb6c-4c44-4e2a-ad72-12c95e6589c97
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1f3eeb6c-4c44-4e2a-ad72-12c95e6589c97
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1f3eeb6c-4c44-4e2a-ad72-12c95e6589c97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-114-1255910011412355 mL in 1 BOTTLE, PLASTIC (55910-114-12) 355 ml2015-03-310000-00-00NoNoCurrent