Repair and Protect

Product NDC
10157-1189
11-digit product format
101571189
Labeler code
10157
Product ID
10157-1189_8bdb42e7-c505-4521-a3a2-1fb67ec9b4c1
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
Blistex Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-05
Substance
PETROLATUM
Active strength
45 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Repair and Protect
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM45 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a51e1b67-e2c7-4b67-95db-07f5f3bdc068Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1189-1Repair and Protect3.69 g in 1 CYLINDERSTICK3.693
10157-1189-1Repair and Protect1 in 1 BLISTER PACKSTICK13
10157-1189-2Repair and Protect2 in 1 BLISTER PACKSTICK23
10157-1189-2Repair and Protect3.69 g in 1 CYLINDERSTICK3.693

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1189REPAIR AND PROTECT (PETROLATUM) STICK [BLISTEX INC.]3Current NDC, 4 package rows20250125_a51e1b67-e2c7-4b67-95db-07f5f3bdc068.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 50 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Watermelon, Tropical Coconut, Peach PassionDIMETHICONEThe Mentholatum Companye9212502-909a-4184-905e-f31a53602c3b2024-12-17WarningsExact identifier
application number: M016
Softlips WatermelonDIMETHICONEThe Mentholatum Companye32d738e-e0af-4f17-a753-bdc7938b16842024-12-17WarningsExact identifier
application number: M016
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
application number: M016
Sweet Cheeks DiaperZINC OXIDETubby Todd4ed0afe1-c893-453e-b4d5-f32561360ec12024-12-17WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
application number: M016
Foster and Thrive Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC298171e1-2826-d33b-e063-6394a90a875a2024-12-17WarningsExact identifier
application number: M016
Secura Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
application number: M016
CVS Maximum Strength Anti-Itch CreamHYDROCORTISONE 1%CVS Healthc2876cba-d7e7-de5c-e053-2a95a90a63552024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc4121d671-521c-4f36-b2db-652c13f730c62024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)DIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c2024-12-16WarningsExact identifier
application number: M016
Balmex Diaper RashZINC OXIDE 11.3%Randob Labs, LTDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b2024-12-15WarningsExact identifier
application number: M016
QC ScarALLANTOIN 0.5%CDMAf7e3d751-a47a-2bca-e053-6394a90a65412024-12-15WarningsExact identifier
application number: M016
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
application number: M016
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10157-1189-1101571189011 CYLINDER in 1 BLISTER PACK (10157-1189-1) / 3.69 g in 1 CYLINDER1 cylinder2023-07-05NoNoCurrent
10157-1189-2101571189022 CYLINDER in 1 BLISTER PACK (10157-1189-2) / 3.69 g in 1 CYLINDER2 cylinder2025-01-21NoNoCurrent