Baby Balm Stick 0.65oz

Product NDC
58503-203
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 29 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrueLipids Relieve and Protect CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c0af9b-f397-dec3-e063-6394a90aed8b2025-12-15WarningsExact identifier
application number: M016
Truelipids TrueLips Lip Balm CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c155dc-f194-6750-e063-6394a90a20b12025-12-15WarningsExact identifier
application number: M016
Aquaphor HealingPETROLATUMBeiersdorf Inc0a17bf6f-6114-4647-a509-65999255c37b2025-12-15WarningsExact identifier
application number: M016
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
application number: M016
Aquaphor Healing Diaper RashZINC OXIDEBeiersdorf Incdec07dfc-67a2-46ad-8fab-828488bdba152025-12-15WarningsExact identifier
application number: M016
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
application number: M016
Aquaphor Lip Protectant and SunscreenPETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBeiersdorf Inca43c2802-9cf1-477e-9f93-e11cf40b480d2025-12-15WarningsExact identifier
application number: M016
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
application number: M016
ECZEMACOLLOIDAL OATMEALSmith Amish, LLC20c4bc16-ba20-47ec-e063-6394a90a8b4e2025-12-12WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEHumco Holding Group, Inc.8c43590d-56ec-4588-8076-99ba94a166852025-12-11WarningsExact identifier
application number: M016
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
application number: M016
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief CreamOATMEALL'Oreal USA Products Inc5d392529-9f0c-40bc-92ca-7003f8e64b1c2025-12-09WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact 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