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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact identifier
application number: M004
BACITRACINBACITRACINCVS Pharmacy15ea4415-943a-4d0a-ac23-5f37cd2cf2062024-10-22WarningsExact identifier
application number: M004
Tetracyte First Aid and Antibiotic TopicalTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INCdcb3d96a-41a5-40d8-a47e-56d419bbe6e22024-10-21WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BCVS Pharmacy3ba24e32-7078-45fb-85d1-2ab252fa9cb52024-10-16WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Inc43486da5-6e8b-45c0-bd7e-cc2d8b28c5102024-10-16WarningsExact identifier
application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin ZincBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production (Xiamen) Co., Ltd.af08c1fe-fb1a-56d2-e053-2a95a90a67c42024-10-15WarningsExact identifier
application number: M004
Exchange Select First Aid Triple Anitbiotic Pain RelievingBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLArmy & Air Force Exchange Service1c7f1700-69c0-4a71-8bb0-a71e3082efeb2024-10-14WarningsExact identifier
application number: M004
antibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E B55fa94cb-7e1c-41bc-879a-5618a828f14a2024-10-14WarningsExact identifier
application number: M004
ndc (product): 37808-005
first aid antibiotic and pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer, Inc.f0892a30-8a88-44e8-ab04-0e87c12f9c442024-10-14WarningsExact identifier
application number: M004
triple antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Incd97a69e8-4058-4c77-b628-ad3e2b97a6202024-10-14WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyb541f1a9-7e40-4c35-840f-ea1e357b580e2024-10-14WarningsExact identifier
application number: M004
Exchange Select triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BArmy & Air Force Exchange Serviceb7bf899c-44e5-48d6-bf8e-d843fd4424322024-10-12WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BTopco Associates LLC675665ee-bd0d-4168-81b8-341b1258c1022024-10-12WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Changjian Medical Products Co., Ltd.34e8776c-1f36-4e1b-9d71-727591ac904d2024-10-11WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BH E B58a4d263-e234-43cd-a3bd-b19a492174d92024-10-11WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC5e0fc39b-e6d4-4543-8afc-2881e2f85f9b2024-10-06WarningsExact identifier
application number: M004
Good Sense Triple Antibiotic and Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companyc3e9215f-fcef-4938-8208-df40996522892024-10-06WarningsExact identifier
application number: M004
triple antibiotic plus maximum strengthBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E Bc428b0a3-e80a-493c-ac67-807ebca3ce012024-10-06WarningsExact identifier
application number: M004
Basic Care First Aid AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmazon.com Services LLCa9247f69-0366-42dd-ae0d-39a2a6976cdc2024-10-06WarningsExact 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