Home NDC 67234-077 NATUREPLEX ANTIBIOTIC
Product NDC 67234-077
11-digit product format 672340077
Labeler code 67234
Product ID 67234-077_7ea2f689-e721-461c-aa87-0b8107889ae1
Type HUMAN OTC DRUG
Nonproprietary name BACITRACIN ZINC and POLYMYXIN B SULFATE
Dosage form CREAM
Route TOPICAL
Labeler Natureplex LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-28
Substance BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength 500; 10000 U/14g; U/14g
Pharmacologic classes 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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N000004-004 PAREDRINE HYDROXYAMPHETAMINE HYDROBROMIDE 1% SOLUTION/DROPS / OPHTHALMIC Approved before 1982
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Additional Listing Data#
Finished product Yes
Brand name base NATUREPLEX ANTIBIOTIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 U/14g POLYMYXIN B SULFATE 10000 U/14g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 19371312D4
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67234-077-01 NATUREPLEX ANTIBIOTIC 1 in 1 CARTON CREAM 1 2 67234-077-01 NATUREPLEX ANTIBIOTIC 14 g in 1 TUBE CREAM 14 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67234-077 NATUREPLEX ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) CREAM [NATUREPLEX LLC] 2 Current NDC, Legacy NDC, 2 package rows 20250119_86ea3452-c810-4c9a-9f52-bcb0688020f9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67234-077-01 67234007701 1 TUBE in 1 CARTON (67234-077-01) / 14 g in 1 TUBE 1 tube 2021-09-28 0000-00-00 No No Current