FDA.reportPublic FDA data

NDC 69968-0634-01 - Neosporin Original

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69968-0634
Requested NDC
69968-0634-01
Package NDCs from labels
69968-0634-1, 69968-0634-9, 69968-0634-01
Manufacturer
Kenvue Brands LLC
Effective date
2024-11-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neosporin Original - Kenvue Brands LLCKenvue Brands LLC2024-11-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0634-1Neosporin Original0.9 g in 1 POUCHOINTMENT0.93
69968-0634-9Neosporin Original144 in 1 CARTONOINTMENT1443
69968-0634-9Neosporin Original0.9 g in 1 POUCHOINTMENT0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0634NEOSPORIN ORIGINAL (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [KENVUE BRANDS LLC]3Current NDC, Legacy NDC, 3 package rows20241116_f07d3bca-4312-46ed-b0c4-f886c01bd095.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0634-1EA - Each69968-063448e340e7-2585-45b5-b631-d2063cb36f3612022-11-07
69968-0634-9EA - Each69968-0634e160c685-db85-4aee-98c2-f7ebc5edf80412022-10-06

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 36 of 58 · 1,148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
unii: 512OYT1CRR
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: 512OYT1CRR
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 4T6H12BN9U
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
unii: 89Y4M234ES
Neomycin and Polymyxin B Sulfates and Bacitracin ZincNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINCBausch & Lomb Incorporatedf3231f1c-665e-4efa-baa1-83bf296b2f8f2025-01-02Warnings, Adverse reactionsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONEBausch & Lomb Incorporated3b00eb5c-dd98-467e-a883-04c37a8ecc422025-01-02Warnings, Adverse reactionsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: 9E8X80D2L0
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: 9E8X80D2L0
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
rxcui: 204602
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
rxcui: 204602
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
unii: 4T6H12BN9U
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
unii: 4T6H12BN9U
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENuCare Pharmaceuticals,Inc.a7e55c43-4345-4710-e053-2995a90aeee72024-12-30Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
unii: 89Y4M234ES
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATENuCare Pharmaceuticals,Inc.a73654f4-949d-3da4-e053-2995a90a1fc32024-12-30Warnings, Adverse reactionsExact identifier
unii: 89Y4M234ES
unii: 19371312D4
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.