FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
41163-367
11-digit product format
411630367
Labeler code
41163
Product ID
41163-367_5cc14fb2-96e1-4f98-a848-81504336f370
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
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
Nighttime Sleep Aid
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
6c9b7576-428a-4884-8331-bb312c9046bdAvailable 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
41163-367-06Nighttime Sleep Aid200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20017
41163-367-06Nighttime Sleep Aid1 in 1 CARTONTABLET, FILM COATED117
41163-367-08Nighttime Sleep Aid2 in 1 CARTONTABLET, FILM COATED217
41163-367-08Nighttime Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED1217
41163-367-12Nighttime Sleep Aid100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
41163-367-12Nighttime Sleep Aid1 in 1 CARTONTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-367-06EA - Each41163-367a0a25f93-72b1-4977-aa23-587d64fa38a912016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-367NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]16Current NDC, Legacy NDC, 6 package rows20250428_6c9b7576-428a-4884-8331-bb312c9046bd.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 6 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company468fa756-1ed6-4652-e063-6294a90a67ea2025-12-22WarningsExact identifier
application number: M010
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company468ff5c6-a6eb-b116-e063-6294a90a84e82025-12-22WarningsExact 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
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f50cc038-0973-4c4b-84a7-1c68f41c24102025-12-04WarningsExact identifier
application number: M010
Vicks ZzzQuil Soothing Sleep Nighttime Sleep-AidDIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company0f8a8291-7468-735e-e063-6394a90a66432025-12-02WarningsExact identifier
application number: M010
Walgreens ChildrensNIGHTTIME COUGHWALGREENS CO.a270cbe3-bf0a-44da-9359-00e218eba2392025-12-01WarningsExact identifier
application number: M010
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.141b00b7-a283-40ab-e063-6294a90aec772025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.1f74e760-9ba9-ac47-e063-6394a90acdff2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLDISCOUNT DRUG MART, INC.116e8192-0c2f-39ed-e063-6294a90abaf32025-12-01WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN6c9b7576-428a-4884-8331-bb312c9046bd17
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD6c9b7576-428a-4884-8331-bb312c9046bd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-367-06411630367061 BOTTLE, PLASTIC in 1 CARTON (41163-367-06) / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent
41163-367-08411630367082 BLISTER PACK in 1 CARTON (41163-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2000-06-100000-00-00NoNoCurrent
41163-367-12411630367121 BOTTLE, PLASTIC in 1 CARTON (41163-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent