FDA.reportPublic FDA data

AD Overnight Healing

Product NDC
65197-404
11-digit product format
651970404
Labeler code
65197
Product ID
65197-404_37c5ce0d-9cc9-4aa0-81e1-b9645765845f
Type
HUMAN OTC DRUG
Nonproprietary name
AD Overnight Healing
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-24
Substance
PETROLATUM
Active strength
47.2 g/100g
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
AD Overnight Healing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM47.2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2683093Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57c29db6-da0c-4b28-86c0-6ac1b7122428Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-404-04AD Overnight Healing1 in 1 BOXOINTMENT14
65197-404-04AD Overnight Healing102 g in 1 TUBEOINTMENT1024
65197-404-15AD Overnight Healing431 g in 1 JAROINTMENT4314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-404AD OVERNIGHT HEALING OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION]4Current NDC, 3 package rows20250110_57c29db6-da0c-4b28-86c0-6ac1b7122428.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 3 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683093petrolatum 47.2 % Topical OintmentPSN57c29db6-da0c-4b28-86c0-6ac1b71224284
2683093petrolatum 0.472 MG/MG Topical OintmentSCD57c29db6-da0c-4b28-86c0-6ac1b71224284
2683093petrolatum 47.2 % Topical OintmentSY57c29db6-da0c-4b28-86c0-6ac1b71224284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-404-04651970404041 TUBE in 1 BOX (65197-404-04) / 102 g in 1 TUBE1 tube2024-05-24NoNoCurrent
65197-404-1565197040415431 g in 1 JAR (65197-404-15) 431 g2024-11-15NoNoCurrent