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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Body Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9d86fc-ef32-baed-e063-6394a90a7d742026-03-12WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact 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