Antibiotic Application

Product NDC
49687-0013
Requested package NDC
49687-0013-0
11-digit product format
496870013
Labeler code
49687
Product ID
49687-0013_2b9b528b-164e-a4d3-e063-6294a90a5318
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CMC Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-06
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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

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 · 7 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-01-11 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 Application
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da436c35-a98f-4df7-9d23-885564734cefAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-01-14Antibiotic Application
2024-01-30Antibiotic Application
2020-02-03Antibiotic Application
2020-01-31Antibiotic Application

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0013-0Antibiotic Application0.9 g in 1 PACKAGEOINTMENT0.97
49687-0013-0Antibiotic Application10 in 1 KITOINTMENT107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0013LARGE ANSI FIRST AID KIT (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]15Current NDC, Legacy NDC20250406_fa8578c2-a0bc-4e2e-a4f9-d48debfff378.zip
49687-0013STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]13Current NDC, Legacy NDC20250406_e1ef74bf-8895-4200-a411-f726dcdaa945.zip
49687-0013REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [CMC GROUP, INC.]9Current NDC, Legacy NDC20250115_45dde3f0-546c-4ec5-beb0-c3d0432f4983.zip
49687-0013ANTIBIOTIC APPLICATION (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [CMC GROUP, INC.]7Current NDC, Legacy NDC, 2 package rows20250116_da436c35-a98f-4df7-9d23-885564734cef.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 1 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
application number: M003
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 0.62 ML/ML Topical GelSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.05 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 0.62 ML/ML Topical GelSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.05 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 0.13 % Medicated PadPSN45dde3f0-546c-4ec5-beb0-c3d0432f49839
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD45dde3f0-546c-4ec5-beb0-c3d0432f49839
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 0.13 % Topical ClothSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 0.13 % Topical SwabSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY45dde3f0-546c-4ec5-beb0-c3d0432f49839
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNda436c35-a98f-4df7-9d23-885564734cef7
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDda436c35-a98f-4df7-9d23-885564734cef7
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYda436c35-a98f-4df7-9d23-885564734cef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49687-0013-04968700130010 PACKAGE in 1 KIT (49687-0013-0) / .9 g in 1 PACKAGE10 package2016-08-060000-00-00NoNoCurrent