Sleep Aid

Product NDC
21130-763
11-digit product format
211300763
Labeler code
21130
Product ID
21130-763_8a6050ec-893c-41d4-b740-b50afd8ad1e7
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-06-10
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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
Brand name suffix
Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dec955d3-817d-454f-b146-9a631e908dbcAvailable 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
21130-763-06Sleep AidNighttime200 in 1 BOTTLETABLET, FILM COATED20016
21130-763-06Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED116
21130-763-08Sleep AidNighttime2 in 1 CARTONTABLET, FILM COATED216
21130-763-08Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1216
21130-763-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED116
21130-763-12Sleep AidNighttime100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-763SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]15Current NDC, Legacy NDC, 6 package rows20250110_dec955d3-817d-454f-b146-9a631e908dbc.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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLEDAMZ789 LLC12dd2419-b2e0-5466-e063-6394a90a42212026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE 50mgDIPHENHYDRAMINE HYDROCHLORIDE 50MGAMZ789 LLCaf0b1b08-e269-6399-e053-2a95a90ac12d2026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.3b1ea33b-8460-31cf-e063-6394a90a55342025-12-31WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLCc1dab616-c3ff-4d0a-be13-e8dc6b1a26cc2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa9678fed-bda5-9513-e053-2995a90a25a12025-12-29WarningsExact identifier
application number: M010
sleep patchesSLEEP PATCHESChangsha Maocheng Trading Co., Ltd25eddec9-1713-c2c8-e063-6394a90af02c2025-12-29WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLC9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.65d1a199-0a8e-41b1-a767-f16e3f91ac942025-12-26WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.837ddc3a-a8d4-454f-974c-979732cb0a222025-12-26WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLDiscount Drug Martac1860cb-da95-45bf-9261-19f39c56ddfe2025-12-23WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLC963c6925-dfbf-4cdc-8d13-5e10b499c4a92025-12-19WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC85391744-3bf5-428e-a77b-464aa95b3a1a2025-12-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b22025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd337a0e6-09ed-4db0-8883-ec8a5d56bd352025-12-11WarningsExact identifier
application number: M010
Topcare ZZZ SleepDIPHENHYDRAMINE HCLTopco Associates LLC27225d04-6deb-436b-89ea-9842c487292e2025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEHEB91426a5b-dc01-a27b-e053-2a95a90a8ff82025-12-09WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life by 7-ElevenDOXYLAMINE SUCCINATE TABLETLil' Drug Store Products, Inc.457814bc-535c-a136-e063-6394a90af9a42025-12-08WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp97eb3e4d-06b7-49ed-909b-95b523dcce412025-12-05WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNdec955d3-817d-454f-b146-9a631e908dbc16
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDdec955d3-817d-454f-b146-9a631e908dbc16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-763-06211300763061 BOTTLE in 1 CARTON (21130-763-06) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2000-06-100000-00-00NoNoCurrent
21130-763-08211300763082 BLISTER PACK in 1 CARTON (21130-763-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2000-06-100000-00-00NoNoCurrent
21130-763-12211300763121 BOTTLE, PLASTIC in 1 CARTON (21130-763-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent