Baby Balm Stick 0.65oz

Product NDC
57337-167
11-digit product format
573370167
Labeler code
57337
Product ID
57337-167_20cf2891-c087-29b4-e063-6294a90a41e8
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rejoice International 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
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
Baby Balm Stick 0.65oz
Listing expiration
2026-12-31

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
20cf3bb8-4ab8-2980-e063-6294a90ad631Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-167-01Baby Balm Stick 0.65oz18.4 g in 1 TUBEOINTMENT18.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-167BABY BALM STICK 0.65OZ (PETROLATUM) OINTMENT [REJOICE INTERNATIONAL CORP.]1Current NDC, 1 package rows20240830_20cf3bb8-4ab8-2980-e063-6294a90ad631.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 30 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
First Aid Beauty FAB Ultra Repair Skin Protectant Chai CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9531-4db4-e063-6394a90a9fd32025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybeb22d69-8a83-65dc-e053-2a95a90ad8122025-12-08WarningsExact identifier
application number: M016
Medicated Hemorrhoidal PadsWITCH HAZELCardinal Health0b49db40-7abc-4e62-b6da-4b9f5b0ae16d2025-12-05WarningsExact identifier
application number: M016
CVS Health MedicatedWITCH HAZELCVS Pharmacya74ab253-cafc-4f00-9b8f-e5c1e6e7f2212025-12-05WarningsExact identifier
application number: M016
Major Medi-PadsWITCH HAZELMajor Pharmaceuticalsd2a314a2-98ab-4ac0-9e90-1a8c1303958f2025-12-05WarningsExact identifier
application number: M016
Good Sense MedicatedWITCH HAZELGeiss, Destin & Dunn, Inc5f122db5-4391-4957-9c25-76834c356c4f2025-12-05WarningsExact identifier
application number: M016
Witch HazelMEDICATED HEMORRHOIDAL WIPESGiant Eaglecdd9d6b7-cbc9-2839-e053-2a95a90ada002025-12-05WarningsExact identifier
application number: M016
Cool ComfortORGANIC WITCH HAZELNaticura Incde14c19c-56b5-4727-9194-94e85425ca8a2025-12-05WarningsExact identifier
application number: M016
GOODSENSE Maximum Strength MedicatedWITCH HAZELGEISS, DESTIN & DUNN, INC5453a12b-e775-4101-bd3a-337857e9e1672025-12-05WarningsExact identifier
application number: M016
Medicated Multipurpose WipesWITCH HAZELQUEST USA CORP.0f28d5f9-b20a-ac6f-e063-6394a90ac2082025-12-05WarningsExact identifier
application number: M016
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALGold Bond Co LLCc292e443-7418-4679-b9b2-4e6d96c04c4c2025-12-05WarningsExact identifier
application number: M016
Prequel Skin Utility OintMULTI PURPOSE SKIN PROTECTANTThe Center Brands, LLC2bf0931e-245d-14a6-e063-6294a90a66812025-12-04WarningsExact identifier
application number: M016
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417854petrolatum 30 % Topical OintmentPSN20cf3bb8-4ab8-2980-e063-6294a90ad6311
417854petrolatum 0.3 MG/MG Topical OintmentSCD20cf3bb8-4ab8-2980-e063-6294a90ad6311
417854petrolatum 30 % Topical OintmentSY20cf3bb8-4ab8-2980-e063-6294a90ad6311
417854petrolatum 30 % Topical StickSY20cf3bb8-4ab8-2980-e063-6294a90ad6311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-167-015733701670118.4 g in 1 TUBE (57337-167-01) 18.4 g2024-08-29NoNoCurrent