AD Skin Protectant

Product NDC
65197-470
11-digit product format
651970470
Labeler code
65197
Product ID
65197-470_45ffedac-d2b6-4783-9c15-ff538ce73a7e
Type
HUMAN OTC DRUG
Nonproprietary name
AD Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-20
Substance
LANOLIN; PETROLATUM
Active strength
15.5; 53.4 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AD Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN15.5 g/100g
PETROLATUM53.4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7EV65EAW6H, 4T6H12BN9U
Rxcui664981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-470-16AD Skin Protectant454 g in 1 JAROINTMENT4545
65197-470-35AD Skin Protectant99 g in 1 TUBEOINTMENT995
65197-470-35AD Skin Protectant1 in 1 BOXOINTMENT15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSNd26f1312-2e1b-4106-bc48-a336d4e034ad5
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCDd26f1312-2e1b-4106-bc48-a336d4e034ad5
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSYd26f1312-2e1b-4106-bc48-a336d4e034ad5
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSYd26f1312-2e1b-4106-bc48-a336d4e034ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-470-1665197047016454 g in 1 JAR (65197-470-16) 454 g2025-03-15NoNoCurrent
65197-470-35651970470351 TUBE in 1 BOX (65197-470-35) / 99 g in 1 TUBE1 tube2025-01-20NoNoCurrent