FDA.reportPublic FDA data

Shopko

Product NDC
37012-027
11-digit product format
370120027
Labeler code
37012
Product ID
37012-027_39fce712-9000-4e1d-e063-6294a90a978a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shopko Stores Operating Co., LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-31
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/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
Shopko
Brand name suffix
Triple Antibiotic plus Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1359350

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37012-027-012024-11-08C16284748780-19d75b9d0-7bb5-f424-e053-dadaa90a57ceShopko ® Triple Antibiotic plus Pain Relief
37012-027-022024-11-08C16284748780-19d75b9d0-7bb5-f424-e053-dadaa90a57ceShopko ® Triple Antibiotic plus Pain Relief
37012-027-012020-01-31C16284748780-19d75b9d0-7bb5-f424-e053-dadaa90a57ceShopko ® Triple Antibiotic plus Pain Relief
37012-027-022020-01-31C16284748780-19d75b9d0-7bb5-f424-e053-dadaa90a57ceShopko ® Triple Antibiotic plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-027-01ShopkoTriple Antibiotic plus Pain Relief1 in 1 CARTONOINTMENT13
37012-027-01ShopkoTriple Antibiotic plus Pain Relief14.2 g in 1 TUBEOINTMENT14.23
37012-027-02ShopkoTriple Antibiotic plus Pain Relief1 in 1 CARTONOINTMENT13
37012-027-02ShopkoTriple Antibiotic plus Pain Relief28.4 g in 1 TUBEOINTMENT28.43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ESSHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
Neomycin sulfateACTIVE INGREDIENT057Y626693SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
Pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
BacitracinACTIVE MOIETY58H6RWO52ISHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
NeomycinACTIVE MOIETYI16QD7X297SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KSHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
PramoxineACTIVE MOIETY068X84E056SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-027SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SHOPKO STORES OPERATING CO., LLC]2Current NDC, Legacy NDC, 4 package rows20241109_5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa.zip

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 OintmentPSN5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa3
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa3
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37012-027-01370120027011 TUBE in 1 CARTON (37012-027-01) / 14.2 g in 1 TUBE1 tube2020-11-30NoNoHistorical
37012-027-02370120027021 TUBE in 1 CARTON (37012-027-02) / 28.4 g in 1 TUBE1 tube2020-11-30NoNoHistorical