ProCoMycin

Product NDC
33261-788
11-digit product format
332610788
Labeler code
33261
Product ID
33261-788_096a2ff6-e875-4d62-bad8-3afa55c8fede
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-10-01
Marketing end
0000-00-00
Substance
BACITRACIN; NEOMYCIN; POLYMYXIN B; LIDOCAINE HYDROCHLORIDE
Active strength
500 [iU]/g; g/g; [iU]/g; g/g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-788IInactivated by FDA2026-10-05
excluded packagepackage33261-78833261-788-01IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-788-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-788-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-788-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-788-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-788-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-788-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-788-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-788-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-788-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-788-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-788-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-788-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-788-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-788-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-788-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-788-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-788-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-788-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-788-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-788-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-788-019bebd1f3094a…5416666fcb17…

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-788-012020-01-31C16284748780-19d75b9d0-4f90-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-788-01ProCoMycin15 g in 1 TUBECREAM155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-788-01GM - Gram33261-788c9d11336-6630-4ef4-a481-df07166c644812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41APROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
NEOMYCINACTIVE INGREDIENTI16QD7X297PROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
POLYMYXIN BACTIVE INGREDIENTJ2VZ07J96KPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
BACITRACINACTIVE MOIETY58H6RWO52IPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
LIDOCAINEACTIVE MOIETY98PI200987PROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
NEOMYCINACTIVE MOIETYI16QD7X297PROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ALLANTOININACTIVE INGREDIENT344S277G0ZPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BUPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1HPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RPROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-788PROCOMYCIN (BACITRACIN, NEOMYCIN, POLYMYXIN B AND LIDOCAIN HYDROCHLORIDE) CREAM [AIDAREX PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20140328_0a94abac-5e83-46bb-94e9-976375b49aa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089101bacitracin 500 UNT/GM / lidocaine HCl 4 % / neomycin 3.5 MG/GM / polymyxin B 10,000 UNT/GM Topical CreamPSN0a94abac-5e83-46bb-94e9-976375b49aa85
1089103ProCoMycin 500 UNT/GM / 4 % / 3.5 MG/GM / 10,000 UNT/GM Topical CreamPSN0a94abac-5e83-46bb-94e9-976375b49aa85
1089103bacitracin 0.5 UNT/ML / lidocaine hydrochloride 40 MG/ML / neomycin 0.0035 MG/ML / polymyxin B 10 UNT/ML Topical Cream [ProCoMycin]SBD0a94abac-5e83-46bb-94e9-976375b49aa85
1089101bacitracin 0.5 UNT/ML / lidocaine hydrochloride 40 MG/ML / neomycin 0.0035 MG/ML / polymyxin B 10 UNT/ML Topical CreamSCD0a94abac-5e83-46bb-94e9-976375b49aa85
1089101bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical CreamSY0a94abac-5e83-46bb-94e9-976375b49aa85
1089103ProCoMycin (bacitracin 0.5 UNT/ML / lidocaine hydrochloride 40 MG/ML / neomycin 0.0035 MG/ML / polymyxin B 10 UNT/ML) Topical CreamSY0a94abac-5e83-46bb-94e9-976375b49aa85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-788-013326107880115 g in 1 TUBE15 gHistorical