FDA.reportPublic FDA data

AD Overnight Healing

Product NDC
65197-404
11-digit product format
651970404
Labeler code
65197
Product ID
65197-404_55f0040f-3b13-482b-b04e-8c1ba8b6bd39
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AD Overnight Healing
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4T6H12BN9U
Rxcui2683093

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

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