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 54 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Love Beauty and PlanetBELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZERConopco Inc. d/b/a/ Unileverba48b351-0d7f-5a41-e053-2a95a90a348c2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED COCONUT AND WARM VANILLA HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ffbf9-7dd0-f685-e053-2995a90a0be02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZERConopco Inc. d/b/a/ Unileverba49e27b-1ade-a75a-e053-2a95a90a18432024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZERConopco Inc. d/b/a/ Unileverba4979a3-ae30-42e4-e053-2995a90abfe72024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSWEET TREATS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0fa3cb-8c25-7511-e053-2995a90a42872024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED LAVENDER AND HYSSOP HAND SANITIZERConopco Inc. d/b/a/ Unileverba484531-ef7b-17ed-e053-2995a90a50b32024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZERConopco Inc. d/b/a/ Unileverba4a573d-def4-a735-e053-2995a90a4f292024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unileverddcb0871-9903-125f-e053-2a95a90a75de2024-11-07WarningsExact identifier
application number: M016
DoveMOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdebc5983-e8bc-c6d5-e053-2995a90af7742024-11-07WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREEConopco Inc. d/b/a/ Unileverdf734b51-33ae-d6b7-e053-2995a90a08cc2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdf73e518-caec-a73b-e053-2995a90a69f52024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER DEEP MOISTUREConopco Inc. d/b/a/ Unileverddca7c55-0a7e-cea6-e053-2995a90ace5a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unileverddcad36b-1909-3bbb-e053-2995a90a295a2024-11-07WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverddcbab1c-7af9-2656-e053-2995a90ad07a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENTConopco Inc. d/b/a/ Unileverdf74d901-c86c-ed71-e053-2995a90a39c22024-11-07WarningsExact identifier
application number: M016
Aveeno Baby Calming Comfort Bath Plus SetDIMETHICONEKenvue Brands LLC2c44fbc7-588f-41e2-953c-eebf24eecbf92024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
application number: M016
Avene XERACALM Eczema Calming Relief BalmCOLLOIDAL OATMEALPierre Fabre USA Inc.1315f006-0e96-2074-e063-6394a90a60372024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea ButterDIMETHICONEKenvue Brands LLCeb71f8b1-bbcd-f338-e053-2995a90a80f12024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Daily MoisturizingCOLLOIDAL OATMEALKenvue Brands LLCe4c85780-7cb2-b55c-e053-2995a90a03142024-11-05WarningsExact 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