Baby Balm Stick 0.65oz

Product NDC
58503-203
Requested package NDC
58503-203-01
11-digit product format
585030203
Labeler code
58503
Product ID
58503-203_21c0b614-ea1a-e98d-e063-6294a90ac44e
Type
HUMAN OTC DRUG
Nonproprietary name
petrolatum ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetics Technology Corp.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-29
Substance
PETROLATUM
Active strength
30 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
Baby Balm Stick 0.65oz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM30 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
417854Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21c0b614-ea19-e98d-e063-6294a90ac44eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-203-01Baby Balm Stick 0.65oz18.4 g in 1 TUBEOINTMENT18.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-203BABY BALM STICK 0.65OZ (PETROLATUM OINTMENT) OINTMENT [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.]1Current NDC, 1 package rows20240911_21c0b614-ea19-e98d-e063-6294a90ac44e.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 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417854petrolatum 30 % Topical OintmentPSN21c0b614-ea19-e98d-e063-6294a90ac44e1
417854petrolatum 0.3 MG/MG Topical OintmentSCD21c0b614-ea19-e98d-e063-6294a90ac44e1
417854petrolatum 30 % Topical OintmentSY21c0b614-ea19-e98d-e063-6294a90ac44e1
417854petrolatum 30 % Topical StickSY21c0b614-ea19-e98d-e063-6294a90ac44e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58503-203-015850302030118.4 g in 1 TUBE (58503-203-01) 18.4 g2024-08-29NoNoCurrent