FDS intimate Whole Body Medicated Chafing

Product NDC
65197-730
11-digit product format
651970730
Labeler code
65197
Product ID
65197-730_6657c175-174e-4843-9152-fc3e3fddeb72
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
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
FDS intimate Whole Body Medicated Chafing
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7EV65EAW6HInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664981Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef01fcd8-2fe4-4076-a4d4-e730a5c2b31cAvailable on FDA.report

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

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 37 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE ZOEUN SKIN TOTAL CARECOLLOIDAL OATMEAL, STURGEON EXTRACTSturgeonbio Co.,Ltd.42712685-64d4-0170-e063-6394a90a75d72025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total CleanserCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4275eecd-67bb-fb1c-e063-6294a90aa09a2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Mist TonerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42766f41-74bc-d19d-e063-6294a90aba532025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Y-Zone Feminine MoisturizerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42773426-f39f-bebe-e063-6394a90a73d92025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Eye CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42792a80-555b-e86c-e063-6294a90a2f302025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Night MaskCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42843691-8761-3f32-e063-6394a90a59bc2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact identifier
application number: M016

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