FDA.reportPublic FDA data

Nighttime Sleep-Aid

Product NDC
76281-522
11-digit product format
762810522
Labeler code
76281
Product ID
76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCI
Dosage form
LIQUID
Route
ORAL
Labeler
AptaPharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Brand name suffix
Non-Habit Forming
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed0ba7aa-e794-43da-b576-6b9945bf7477Available 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
76281-522-24Nighttime Sleep-AidNon-Habit Forming118 mL in 1 BOTTLELIQUID1183
76281-522-25Nighttime Sleep-AidNon-Habit Forming177 mL in 1 BOTTLELIQUID1773
76281-522-28Nighttime Sleep-AidNon-Habit Forming354 mL in 1 BOTTLELIQUID3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-522NIGHTTIME SLEEP-AID NON-HABIT FORMING (DIPHENHYDRAMINE HCI) LIQUID [APTAPHARMA INC.]3Current NDC, Legacy NDC, 3 package rows20231231_ed0ba7aa-e794-43da-b576-6b9945bf7477.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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
application number: M017
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
application number: M017
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
application number: M017
LavaDerm AfterSunMENTHOLYoung Living Essential Oils, LC.4fcddcf1-36db-2f1a-e054-00144ff8d46c2026-04-15WarningsExact identifier
application number: M017
Arlun Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f8b60f9-03e3-e731-e063-6294a90a3b0a2026-04-15WarningsExact identifier
application number: M017
tuiwaro Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f66178c-95d9-8c6a-e063-6294a90a2c092026-04-14WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
application number: M017
Signature Pain Relief Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4f555b8f-5193-e685-e063-6294a90a7ba22026-04-13WarningsExact identifier
application number: M017
Deep Numbing CreamMENTHOLYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD7943559b-de10-4214-96dc-f9cbac828f462026-04-13WarningsExact identifier
application number: M017
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8465b443-abe9-78fb-e053-2a91aa0ac1d82026-04-13WarningsExact identifier
application number: M017
4JointzMENTHOLARP(USA) Pty Ltd94a5b5f5-abf7-40b3-9dd7-43e2c22f138e2026-04-13WarningsExact identifier
application number: M017
Sumifun Pain Relief CreamsMETHYL SALICLATE CAPSAICIN CAMPHORGuchutang Biotechnology (Longyan) Co., Ltd4f3dd96a-d843-d810-e063-6394a90a188e2026-04-12WarningsExact identifier
application number: M017
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Gel PatchCAPSAICIN, MENTHOLVeridian Healthcaref5484151-b6da-4f64-867f-87160a4ec2d62026-04-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNed0ba7aa-e794-43da-b576-6b9945bf74773
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDed0ba7aa-e794-43da-b576-6b9945bf74773
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYed0ba7aa-e794-43da-b576-6b9945bf74773
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYed0ba7aa-e794-43da-b576-6b9945bf74773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-522-2476281052224118 mL in 1 BOTTLE (76281-522-24) 118 ml2018-01-010000-00-00NoNoCurrent
76281-522-2576281052225177 mL in 1 BOTTLE (76281-522-25) 177 ml2018-01-010000-00-00NoNoCurrent
76281-522-2876281052228354 mL in 1 BOTTLE (76281-522-28) 354 ml2018-01-010000-00-00NoNoCurrent