FDA.reportPublic FDA data

Sleep Aid

Product NDC
49035-367
11-digit product format
490350367
Labeler code
49035
Product ID
49035-367_7affd665-60d0-4b01-96be-a9f2db49f2bf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
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
cfddfdeb-701f-452d-876d-8003e6fcefe3Available 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
49035-367-08Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1215
49035-367-08Sleep AidNighttime2 in 1 CARTONTABLET, FILM COATED215
49035-367-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED115
49035-367-12Sleep AidNighttime100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
49035-367-42Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1215

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-367SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]14Current NDC, Legacy NDC, 5 package rows20240612_cfddfdeb-701f-452d-876d-8003e6fcefe3.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 11 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Inc.6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f2024-12-02WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incb45296a9-e3f0-a4cb-e053-2995a90a16862024-12-02WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLCVS Pharmacy, Inc.6dd802ec-fc26-3913-e053-2a91aa0ad05d2024-12-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC236ff457-0ec1-9c49-e063-6394a90a707a2024-11-26WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.50d74111-6d1b-4681-a264-f7e5503202592024-11-25WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.efb05387-72c0-4643-8541-b7990c202ce62024-11-25WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6ozDIPHENHYDRAMINE HCL SOLUTIONLil' Drug Store Products, Inc.2781fc28-8a7d-d0fa-e063-6394a90ac7932024-11-22WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7830ce18-908a-4f86-a238-8c31cfe47ce62024-11-21WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.f8de6605-4a0a-492d-beb5-f414ce8bfb0e2024-11-20WarningsExact identifier
application number: M010
Nighttime SLEEP AIDDIPHENHYDRAMINE HCL 50MGPuraCap Pharmaceutical LLC272a7138-2a97-8e62-e063-6394a90a1af12024-11-18WarningsExact identifier
application number: M010
ZzzQuilDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.0b2777be-85d4-443d-b65f-6750e0ba97ba2024-11-18WarningsExact identifier
application number: M010
RiteAid Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENRITE AID CORPORATION54fc0893-9702-4849-a702-3e84dc9ead032024-10-30WarningsExact identifier
application number: M010
Rite Aid Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDERITE AID CORPORATION59ba6824-fa6c-4b3f-9f1f-ea194766c8a12024-10-30WarningsExact identifier
application number: M010
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
application number: M010
Premier Value Nighttime Sleep-Aid Liquid Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Consortium6d24b6e1-7959-47c6-a09b-c7e00a4374952024-10-28WarningsExact identifier
application number: M010
NytolDIPHENHYDRAMINE HCLMedtech Products Inc.c81d018a-0170-4396-81e9-2e13a53f868a2024-10-25WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.2ab3852d-53a4-411b-a9ad-3ef88ab3ee872024-10-23WarningsExact identifier
application number: M010
nitetime sleep aidDIPHENHYDRAMINE HCLMeijer Distribution Inc43184abd-2525-402a-a388-85af2e5c13ad2024-10-17WarningsExact identifier
application number: M010
Good Sense Sleep TimeDIPHENHYDRAMINE HCLL. Perrigo Company164200a9-b1f8-44c9-8598-a7dff5020e9d2024-10-16WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNcfddfdeb-701f-452d-876d-8003e6fcefe315
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDcfddfdeb-701f-452d-876d-8003e6fcefe315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-367-08490350367082 BLISTER PACK in 1 CARTON (49035-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2000-06-100000-00-00NoNoCurrent
49035-367-12490350367121 BOTTLE, PLASTIC in 1 CARTON (49035-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent
49035-367-424903503674212 TABLET, FILM COATED in 1 BLISTER PACK (49035-367-42) 2000-06-100000-00-00NoNoCurrent