Home NDC 0713-0268 Triple Antibiotic
Product NDC 0713-0268
11-digit product format 007130268
Labeler code 0713
Product ID 0713-0268_0cf1cf3a-c318-a32a-e063-6394a90a884d
Type HUMAN OTC DRUG
Nonproprietary name Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 1995-01-11
Substance POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
Active strength 5000; 3.5; 400 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0713-0268-31 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0713-0268-31 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0713-0268-31 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0713-0268-31 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0713-0268-31 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0713-0268-31 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Triple Antibiotic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYMYXIN B SULFATE 5000 [USP'U]/g NEOMYCIN SULFATE 3.5 mg/g BACITRACIN ZINC 400 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19371312D4 Internal UNII lookup 057Y626693 Internal UNII lookup 89Y4M234ES Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204602 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0713-0268-31 Triple Antibiotic 28.4 g in 1 TUBE OINTMENT 28.4 3 0713-0268-31 Triple Antibiotic 1 in 1 CARTON OINTMENT 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bacitracin Zinc ACTIVE INGREDIENT 89Y4M234ES TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Neomycin ACTIVE INGREDIENT I16QD7X297 TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Polymyxin B Sulfate ACTIVE INGREDIENT 19371312D4 TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Bacitracin ACTIVE MOIETY 58H6RWO52I TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Neomycin ACTIVE MOIETY I16QD7X297 TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Polymyxin B ACTIVE MOIETY J2VZ07J96K TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0268 TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE) OINTMENT [COSETTE PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231221_39893365-c94f-bc83-67f6-0005d5f2aa24.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 22 of 22 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
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 0713-0268-31 00713026831 1 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE 1 tube 1995-01-11 0000-00-00 No No Current