Home NDC 67234-081 Natureplex Antibiotic plus Pain
Product NDC 67234-081
11-digit product format 672340081
Labeler code 67234
Product ID 67234-081_fb94d8fa-2b35-4f64-8d0d-1eef93982e99
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin zinc, Neomycin sulfate, POLYMYXIN B SULFATE, and Pramoxine hydrochloride
Dosage form OINTMENT
Route TOPICAL
Labeler Natureplex, LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-14
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/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 2027-12-31
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. Not for prolonged use. Do not use in the eyes, nose, or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days a rash, redness, irritation, swelling, or pain persists or increases, 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 plus Pain
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [iU]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [iU]/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5 Rxcui 1359350
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 67234-081-01 Natureplex Antibiotic plus Pain 28 g in 1 TUBE OINTMENT 28 2 67234-081-01 Natureplex Antibiotic plus Pain 1 in 1 CARTON OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67234-081 NATUREPLEX ANTIBIOTIC PLUS PAIN (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [NATUREPLEX LLC] 1 Current NDC, Legacy NDC, 2 package rows 20211217_317acec2-8ab7-4b62-9d72-f98cab4f979c.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 67234-081-01 67234008101 1 TUBE in 1 CARTON (67234-081-01) / 28 g in 1 TUBE 1 tube 2021-12-14 0000-00-00 No No Current