FDS intimate Whole Body Medicated Chafing

Product NDC
65197-730
11-digit product format
651970730
Labeler code
65197
Product ID
65197-730_8a0b3a1a-89f3-4d55-a0ed-6e3cae6937d8
Type
HUMAN OTC DRUG
Nonproprietary name
FDS intimate Whole Body Medicated Chafing
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-31
Substance
LANOLIN; PETROLATUM
Active strength
15.5; 53.4 g/100g; 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
FDS intimate Whole Body Medicated Chafing
Listing expiration
2026-12-31

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
65197-730-15FDS intimate Whole Body Medicated Chafing42.5 g in 1 TUBEOINTMENT42.51
65197-730-15FDS intimate Whole Body Medicated Chafing1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-730FDS INTIMATE WHOLE BODY MEDICATED CHAFING OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION]1Current NDC, 2 package rows20250206_ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSNef01fcd8-2fe4-4076-a4d4-e730a5c2b31c1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCDef01fcd8-2fe4-4076-a4d4-e730a5c2b31c1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSYef01fcd8-2fe4-4076-a4d4-e730a5c2b31c1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSYef01fcd8-2fe4-4076-a4d4-e730a5c2b31c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-730-15651970730151 TUBE in 1 BOX (65197-730-15) / 42.5 g in 1 TUBE1 tube2025-01-31NoNoCurrent