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 21 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELTopco Associates LLC471a9f8d-ba12-41d3-a510-20c1a13ff8502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWakefern Food Corp.b799229b-f7ca-494c-afde-1fd096aef66e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWinCo Foods, LLC659cc8c7-6300-41c0-a684-c5fde7f2b1002026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDEWalgreen Co.220f70e1-0802-4fe2-92d0-78dec557c9932026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELWalgreen Co.417ae199-54bb-420f-a3cf-1c096062d78c2026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4a93d029-d721-0bb5-e063-6294a90a17c42026-02-11WarningsExact identifier
application number: M016
Natouch Eczema WipesECZEMA WIPESNatouch LLC0a9756a4-2fa9-cd19-e063-6294a90a93ad2026-02-10WarningsExact identifier
application number: M016
EARTHS CARE Eczema CreamECZEMADLC Laboratories, Inc.17436fa0-d6c7-1052-e063-6294a90adae42026-02-09WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf0c9494-0138-4346-9348-e235ca4d9e582026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATERetail Business Services, LLCa80b8fee-2dd9-4640-a4f8-4cf940df85632026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRetail Business Services, LLC6e9121c8-5eb9-4d0b-86c5-b892e14bdab82026-02-06WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf73c618-ed2f-4468-a51f-ff61c7b1f5062026-02-06Warnings, Adverse reactionsExact 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