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; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength
3.5; 10; 10000 mg/g; mg/g; [USP'U]/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

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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
88AYB867L5Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359360Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55fa94cb-7e1c-41bc-879a-5618a828f14aAvailable on FDA.report

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

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 7 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin ZincBACITRACIN ZINCHenry Scheineaf1555d-7a3d-7ccb-e053-2995a90af62e2025-11-25WarningsExact identifier
application number: M004
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin SulfateBACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATEHenry Scheineadb847e-aefe-41cf-e053-2995a90af2cd2025-11-25WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact identifier
application number: M004
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsExact identifier
application number: M004
dabur First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEDabur India Limited229170a3-ef9e-597d-e063-6394a90acf8b2025-11-18WarningsExact identifier
application number: M004
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
application number: M004
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
application number: M004
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
application number: M004
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
application number: M004
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
application number: M004
Rapidol Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPharmadel LLC1ad22205-f8c3-b142-e063-6394a90a00442025-11-17WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsExact identifier
application number: M004
ElixirBaciShield First AidBACITRACIN ZINCELIXIR HEALTHCARE USA, LLC.15e31a2a-01b5-4598-850f-4d0348086b4b2025-11-12WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC4352c453-a89c-a2b9-e063-6294a90a61f32025-11-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCUniversal Distribution Center LLC186b2750-5bf6-1702-e063-6294a90a62b32025-10-30WarningsExact identifier
application number: M004
POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATEGRANDALL DISTRIBUTING, LLC1d8e1fca-6864-7c08-e063-6394a90a08b62025-10-28WarningsExact identifier
application number: M004
POLVO DE SULFA FIRST AID ANTIBIOTICBACITRACIN ZINC, POLYMYXIN B SULFATEGRANDALL DISTRIBUTING, LLC1d8e3a03-a39f-a99e-e063-6394a90a31db2025-10-28WarningsExact identifier
application number: M004
EasyTouch Alcohol Prep Pads SterileISOPROPYL ALCOHOLMHC Medical Products, LLCfd60ad34-5fd9-4440-9f3f-23beffc19dd92025-10-24WarningsExact identifier
application number: M004

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