Sleep Aid

Product NDC
55910-894
11-digit product format
559100894
Labeler code
55910
Product ID
55910-894_5236c556-3a0d-47ea-9dc6-834b0761cbc5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-18
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
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
Sleep Aid
Listing expiration
2027-12-31

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
e0da439f-7e23-4e60-8d16-b607aa41ed17Available 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
55910-894-16Sleep Aid16 in 1 CARTONCAPSULE162
55910-894-16Sleep Aid1 in 1 BLISTER PACKCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-894SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2Current NDC, 2 package rows20240229_e0da439f-7e23-4e60-8d16-b607aa41ed17.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 9 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d64f5c2-dfa9-e5f5-e063-6294a90a07112025-03-19WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLHarris Teeter, LLC322a71bb-fc68-4a03-8a24-20cbdbe6d91b2025-03-13WarningsExact identifier
application number: M010
REVASOL SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.1a7189ba-2d52-44fc-83a4-b9f6156c62ff2025-03-07WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
application number: M010
Allergy Relief 25 mgDIPHENHYDRAMINE HCL 25MGUlai Health LLC751f13d4-c4d6-47a5-b40d-1563de08c0482025-01-12WarningsExact identifier
application number: M010
RoboCoughDEXTROMETHORPHAN HBRDXM Pharmacuetical, Inc.32fa7a09-8624-44c1-b9e4-8a8f0594292b2025-01-10WarningsExact identifier
application number: M010
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.971515fa-b4d2-1197-e053-2995a90a838d2025-01-03WarningsExact identifier
application number: M010
Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC8b0fa259-6702-4667-bac6-f7d0b0839ae02025-01-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC9f1c078d-e537-4ec0-8ae9-54c98282be292024-12-31WarningsExact identifier
application number: M010
Discount Drugmart Nighttime Sleep-AidDIPHENHYDRAMINE HCLDiscount Drug Mart, Incd6d77c2e-42b3-48f0-a662-3872155ef34d2024-12-18WarningsExact identifier
application number: M010
Kroger Nighttime Sleep-AidDIPHENHYDRAMINE HCLTHE KROGER CO98437a72-1b98-4301-b92f-0c17b305cf592024-12-18WarningsExact identifier
application number: M010
equate nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.6e162152-b414-470c-b146-649d998705772024-12-17WarningsExact identifier
application number: M010
Quality Choice Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association, Inc.e8b2858b-a737-c500-e053-2995a90adba62024-12-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.f99cc210-b946-42a2-9164-8aa5308c54182024-12-11WarningsExact identifier
application number: M010
CalmCo Sleep Aid Gummy BiteDIPHENHYDRAMINE HCLCalmCo LLC0c534cbd-40e6-8af0-e063-6394a90a56052024-12-07WarningsExact identifier
application number: M010
Somnapure Clinical StrengthDIPHENHYDRAMINE HYDROCHLORIDEForce Factor Brands LLC063517c0-bcb1-46dd-85f1-bbb2f24274ef2024-12-06WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNe0da439f-7e23-4e60-8d16-b607aa41ed172
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDe0da439f-7e23-4e60-8d16-b607aa41ed172
1020477diphenhydramine HCl 50 MG Oral CapsuleSYe0da439f-7e23-4e60-8d16-b607aa41ed172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-894-165591008941616 BLISTER PACK in 1 CARTON (55910-894-16) / 1 CAPSULE in 1 BLISTER PACK16 blister pack2021-03-18NoNoCurrent