FDA.reportPublic FDA data

CAREALL Bacitracin

Product NDC
51824-003
11-digit product format
518240003
Labeler code
51824
Product ID
51824-003_4500451e-fef7-66b4-e063-6294a90a8ecc
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
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
CAREALL Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea16e1de-0100-456b-abe6-d33de78221daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-003-01CAREALL Bacitracin28 g in 1 TUBECREAM2814
51824-003-09CAREALL Bacitracin0.9 g in 1 PACKETCREAM0.914
51824-003-14CAREALL Bacitracin144 in 1 CARTONCREAM14414
51824-003-25CAREALL Bacitracin25 in 1 CARTONCREAM2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-003-01GM - Gram51824-003c8c68dd7-7db2-4357-8a9f-647f6ab81f8c12020-03-10
51824-003-09EA - Each51824-0031af31d01-0f5c-4b89-9c1c-8d880b1c408012024-08-12
51824-003-14EA - Each51824-00382bc5025-de54-4f90-83a6-8c24f06ec3ee12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESCAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]5
Bacitracin ZincACTIVE MOIETY89Y4M234ESCAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]5
Mineral OilINACTIVE INGREDIENTT5L8T28FGPCAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]5
ParaffinINACTIVE INGREDIENTI9O0E3H2ZECAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]5
PetrolatumINACTIVE INGREDIENT4T6H12BN9UCAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-003CAREALL BACITRACIN (BACITRACIN ZINC) CREAM [NEW WORLD IMPORTS, INC]11Current NDC, Legacy NDC, 4 package rows20231014_ea16e1de-0100-456b-abe6-d33de78221da.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 12 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Front Pharmaceutical PLC3244d91e-6c6b-a351-e063-6294a90aa02d2025-04-08WarningsExact identifier
application number: M004
Walgreens Advanced Wound HydrogelALLANTOIN, BENZETHONIUM CHLORIDEWALGREEN COMPANY25c6ada8-4a16-0896-e063-6294a90a0fdb2025-04-08WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
application number: M004
burn gel 01MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILCosmuses Cosmetics (Ningbo) Co., Ltd.3227bdc9-9323-68eb-e063-6294a90a29d22025-04-06WarningsExact identifier
application number: M004
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
application number: M004
Vitastem Ultra First Aid AntibioticBACITRACIN ZINCViaderma Distribution Ince6986bf9-22ea-4484-a709-27bc91c9058d2025-03-18WarningsExact identifier
application number: M004
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLC0ad21575-0e2d-24c2-e063-6394a90a616e2025-02-21WarningsExact identifier
application number: M004
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
application number: M004
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsExact identifier
application number: M004
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
application number: M004
EquateBACITRACIN ZINC ANTIBIOTIC OINTMENTWalmart Inc.20908780-8803-4e19-e063-6394a90aab872025-02-01WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-003-015182400030128 g in 1 TUBE (51824-003-01) 28 g2012-06-010000-00-00NoNoCurrent
51824-003-0951824000309.9 g in 1 PACKET (51824-003-09) 2017-06-010000-00-00NoNoCurrent
51824-003-1451824000314144 PACKET in 1 CARTON (51824-003-14) / .9 g in 1 PACKET (51824-003-09) 144 packet2022-05-010000-00-00NoNoCurrent
51824-003-255182400032525 PACKET in 1 CARTON (51824-003-25) / .9 g in 1 PACKET (51824-003-09) 25 packet2022-05-010000-00-00NoNoCurrent