FDA.reportPublic FDA data

antibiotic

Product NDC
37808-005
11-digit product format
378080005
Labeler code
37808
Product ID
37808-005_9fd3e906-9a3a-4640-aff6-8237eb1c5980
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin, Polymyxin B, Pramoxine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-14
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693, 19371312D4, 88AYB867L5
Rxcui1359360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-005-58antibiotic1 in 1 CARTONCREAM13
37808-005-58antibiotic14 g in 1 TUBECREAM143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
NEOMYCINACTIVE MOIETYI16QD7X297ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
PRAMOXINEACTIVE MOIETY068X84E056ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-005ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]3Current NDC, Legacy NDC, 2 package rows20241016_55fa94cb-7e1c-41bc-879a-5618a828f14a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN55fa94cb-7e1c-41bc-879a-5618a828f14a3
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD55fa94cb-7e1c-41bc-879a-5618a828f14a3
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY55fa94cb-7e1c-41bc-879a-5618a828f14a3
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY55fa94cb-7e1c-41bc-879a-5618a828f14a3
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY55fa94cb-7e1c-41bc-879a-5618a828f14a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-005-58378080005581 TUBE in 1 CARTON (37808-005-58) / 14 g in 1 TUBE1 tube2015-09-140000-00-00NoNoCurrent