FDA.reportPublic FDA data

equaline first aid antibiotic

Product NDC
41163-040
11-digit product format
411630040
Labeler code
41163
Product ID
41163-040_ad90da8b-fd08-4368-a15a-5d220edabae2
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Supervalu Inc
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-02
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; mg/g; [USP'U]/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41163-040IInactivated by FDA2026-10-12
excluded packagepackage41163-04041163-040-58DDiscontinued by firm2026-10-12
excluded packagepackage41163-04041163-040-64IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
41163-040-582026-01-29C16284748780-149896155-aad5-586f-e063-e6dba90add90SuperValu, Inc. First Aid Antibiotic Drug Facts
41163-040-642026-01-29C16284748780-149896155-aad5-586f-e063-e6dba90add90SuperValu, Inc. First Aid Antibiotic Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-040-58equaline first aid antibiotic1 in 1 CARTONOINTMENT15
41163-040-58equaline first aid antibiotic14 g in 1 TUBEOINTMENT145
41163-040-64equaline first aid antibiotic1 in 1 CARTONOINTMENT15
41163-040-64equaline first aid antibiotic28 g in 1 TUBEOINTMENT285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-040-58GM - Gram41163-040e6ac8f5f-da5c-4113-a9e6-8e4f16ec52ad12016-10-06
41163-040-64GM - Gram41163-04078734507-7dcb-4483-8a9b-e2478e6193b312016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESEQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
BACITRACINACTIVE MOIETY58H6RWO52IEQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
NEOMYCINACTIVE MOIETYI16QD7X297EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KEQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
PRAMOXINEACTIVE MOIETY068X84E056EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [SUPERVALU INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-040EQUALINE FIRST AID ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI]5Legacy NDC, 4 package rows20241008_de2fd85d-25b2-40ec-a6a5-5994cd1480c9.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 OintmentPSNde2fd85d-25b2-40ec-a6a5-5994cd1480c95
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDde2fd85d-25b2-40ec-a6a5-5994cd1480c95
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYde2fd85d-25b2-40ec-a6a5-5994cd1480c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-040-58411630040581 TUBE in 1 CARTON (41163-040-58) > 14 g in 1 TUBE1 tube2015-04-020000-00-00NoNoCurrent
41163-040-64411630040641 TUBE in 1 CARTON (41163-040-64) > 28 g in 1 TUBE1 tube2015-04-020000-00-00NoNoCurrent