FDA.reportPublic FDA data

Antibiotic Plus Pain Relief

Product NDC
11673-393
11-digit product format
116730393
Labeler code
11673
Product ID
11673-393_39ac025d-b45a-f3ed-e063-6394a90a5543
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
TARGET Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-16
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
3.5; 10000; 10 mg/g; [iU]/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

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 Plus Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal 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
6fba5890-f48f-4302-a8ac-5087a6e03bd5Available 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
11673-393-01Antibiotic Plus Pain Relief1 in 1 CARTONCREAM14
11673-393-01Antibiotic Plus Pain Relief14.2 g in 1 TUBECREAM14.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-393ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TARGET CORPORATION]3Current NDC, Legacy NDC, 2 package rows20241114_6fba5890-f48f-4302-a8ac-5087a6e03bd5.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 88 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact identifier
application number: M017

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 CreamPSN6fba5890-f48f-4302-a8ac-5087a6e03bd54
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD6fba5890-f48f-4302-a8ac-5087a6e03bd54
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY6fba5890-f48f-4302-a8ac-5087a6e03bd54
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY6fba5890-f48f-4302-a8ac-5087a6e03bd54
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY6fba5890-f48f-4302-a8ac-5087a6e03bd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-393-01116730393011 TUBE in 1 CARTON (11673-393-01) / 14.2 g in 1 TUBE1 tube2020-10-160000-00-00NoNoCurrent