antibiotic

Generic: neomycin, polymyxin b, pramoxine hcl

Labeler: h e b
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antibiotic
Generic Name neomycin, polymyxin b, pramoxine hcl
Labeler h e b
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-005
Product ID 37808-005_9fd3e906-9a3a-4640-aff6-8237eb1c5980
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2015-09-14

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808005
Hyphenated Format 37808-005

Supplemental Identifiers

RxCUI
1359360
UPC
0041220586851
UNII
057Y626693 19371312D4 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name antibiotic (source: ndc)
Generic Name neomycin, polymyxin b, pramoxine hcl (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (37808-005-58) / 14 g in 1 TUBE
source: ndc

Packages (1)

37808-005-58 1 TUBE in 1 CARTON (37808-005-58) / 14 g in 1 TUBE

Ingredients (3)

neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "9fd3e906-9a3a-4640-aff6-8237eb1c5980", "openfda": {"upc": ["0041220586851"], "unii": ["057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359360"], "spl_set_id": ["55fa94cb-7e1c-41bc-879a-5618a828f14a"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (37808-005-58)  / 14 g in 1 TUBE", "package_ndc": "37808-005-58", "marketing_start_date": "20150914"}], "brand_name": "antibiotic", "product_id": "37808-005_9fd3e906-9a3a-4640-aff6-8237eb1c5980", "dosage_form": "CREAM", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "37808-005", "generic_name": "Neomycin, Polymyxin B, Pramoxine HCl", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "antibiotic", "active_ingredients": [{"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150914", "listing_expiration_date": "20261231"}