FDA.reportPublic FDA data

Caring Mill Triple Antibiotic and Pain

Product NDC
81522-050
Requested package NDC
81522-050-01
11-digit product format
815220050
Labeler code
81522
Product ID
81522-050_47221961-b3f5-9626-e063-6394a90a107e
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
FSA Store Inc. (Caring Mills)
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], 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
Caring Mill Triple Antibiotic and Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c5b6909-6b30-5256-e063-6294a90a9096Available 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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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
81522-050-01Caring Mill Triple Antibiotic and Pain1 in 1 PACKAGEOINTMENT13
81522-050-01Caring Mill Triple Antibiotic and Pain28.3 g in 1 TUBEOINTMENT28.33

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 1 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
application number: M004
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
application number: M004
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
application number: M004
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
application number: M004
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
application number: M004
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
application number: M004
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN3c5b6909-6b30-5256-e063-6294a90a90963
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD3c5b6909-6b30-5256-e063-6294a90a90963
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY3c5b6909-6b30-5256-e063-6294a90a90963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81522-050-01815220050011 TUBE in 1 PACKAGE (81522-050-01) / 28.3 g in 1 TUBE1 tube2025-10-01NoNoCurrent