FDA.reportPublic FDA data

Sleep Aid

Product NDC
55910-798
11-digit product format
559100798
Labeler code
55910
Product ID
55910-798_6d10ff6d-37fd-4107-bb19-22496532cda7
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-18
Marketing end
2028-07-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
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
Sleep Aid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

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
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
651b03a3-b85e-4028-a9f2-472bec16c8f4Available 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
55910-798-16Sleep Aid1 in 1 BLISTER PACKCAPSULE11
55910-798-16Sleep Aid16 in 1 CARTONCAPSULE161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-798SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1Current NDC, 2 package rows20240229_651b03a3-b85e-4028-a9f2-472bec16c8f4.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 46 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and NighttimeACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP43da4211-3bb3-0a8e-e063-6294a90a4fcd2026-03-16WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLKroger Companyab12c975-2085-4365-9c4b-0be573a260c42026-03-13WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC88e3e51a-c9a5-43f9-b9d7-97509c607df12026-03-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCLRB Health (US) LLC4cc490a6-a27a-a25b-e063-6294a90a3a952026-03-11WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCba6d69ff-b392-4f21-b3d7-00d8ec5dee322026-03-11WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEB40091b98-b4c7-4a3b-e063-6294a90abd5d2026-03-10WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEUnited Natural Foods, Inc. dba UNFI0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATETopco Associates, LLC35305aa9-4fc1-4cda-b6f0-89df64f9eeff2026-03-10WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway03332596-2c37-4771-b13b-ab766e6168662026-03-10WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief Maximum StrengthPSEUDOEPHEDRINE HCLRite Aid Corporationd86140ab-1117-4d14-a380-f5cc375775a12026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN4c9cca86-41bf-1635-e063-6294a90a17fb2026-03-09WarningsExact identifier
application number: M012
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.447a8753-96bd-676a-e063-6394a90a48f22026-03-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN651b03a3-b85e-4028-a9f2-472bec16c8f41
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD651b03a3-b85e-4028-a9f2-472bec16c8f41
1020477diphenhydramine HCl 50 MG Oral CapsuleSY651b03a3-b85e-4028-a9f2-472bec16c8f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-798-165591007981616 BLISTER PACK in 1 CARTON (55910-798-16) / 1 CAPSULE in 1 BLISTER PACK16 blister pack2021-03-182028-07-28NoNoHistorical