Home NDC 67510-0631-1 Triple Antibiotic
Product NDC 67510-0631
Requested package NDC 67510-0631-1
11-digit product format 675100631
Labeler code 67510
Product ID 67510-0631_b147610f-f41c-c9cb-e053-2a95a90a658f
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Dosage form OINTMENT
Route TOPICAL
Labeler Kareway Product, Inc.
Application part333B
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-12-12
Marketing end 0000-00-00
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400 [USP'U]/g; mg/g; [USP'U]/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67510-0631-1 Triple Antibiotic 28.3 g in 1 TUBE OINTMENT 28.3 5 67510-0631-1 Triple Antibiotic 1 in 1 BOX OINTMENT 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BACITRACIN ZINC ACTIVE INGREDIENT 89Y4M234ES TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 BACITRACIN ACTIVE MOIETY 58H6RWO52I TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 NEOMYCIN ACTIVE MOIETY I16QD7X297 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE, D- INACTIVE INGREDIENT A7E6112E4N TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67510-0631 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.] 5 Legacy NDC, 2 package rows 20230129_b249ea8c-5418-4189-a39b-ce0174fa60c6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0631-1 67510063101 1 TUBE in 1 BOX (67510-0631-1) > 28.3 g in 1 TUBE 1 tube 2013-12-12 0000-00-00 No No Current