Home NDC 70677-1218 Antibiotic and Pain Relief
Product NDC 70677-1218
11-digit product format 706771218
Labeler code 70677
Product ID 70677-1218_4d4f1d08-e4be-c0bc-e063-6294a90ae949
Type HUMAN OTC DRUG
Nonproprietary name Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler STRATEGIC SOURCING SERVICES LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-24
Marketing end 2027-03-31
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Current FDA listing Yes 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 Antibiotic and Pain Relief Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [USP'U]/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 057Y626693 Internal UNII lookup 19371312D4 Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359360 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70677-1218-1 Antibiotic and Pain Relief 1 in 1 CARTON CREAM 1 3 70677-1218-1 Antibiotic and Pain Relief 14.2 g in 1 TUBE CREAM 14.2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-1218 ANTIBIOTIC AND PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [STRATEGIC SOURCING SERVICES LLC] 1 Current NDC, 2 package rows 20240129_f7aa9330-c47c-4d2f-b784-11b831d919d6.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 73 of 152 · 3,029 matching rows.
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 70677-1218-1 70677121801 1 TUBE in 1 CARTON (70677-1218-1) / 14.2 g in 1 TUBE 1 tube 2024-01-24 2027-03-31 No No Historical