FDA.reportPublic FDA data

Premier Value Max Strength Antibiotic plus pain relief

Product NDC
68016-296
11-digit product format
680160296
Labeler code
68016
Product ID
68016-296_29b70a0d-e3fe-db95-e063-6394a90adfb2
Type
HUMAN OTC DRUG
Nonproprietary name
Premier Value Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-22
Substance
NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength
3.5; 10; 10000 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-296-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-296-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-296-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68016-296-058dfbde2a14a4…c9ff85d89658…

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
Premier Value Max Strength Antibiotic plus pain relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
88AYB867L5Internal 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
1359360Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9767821e-054b-3bd3-e053-2a95a90a4b0eAvailable 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
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
68016-296-052023-05-09C16284748780-1ba0f9c33-167d-a910-e053-dadaa90a0b85Maximum Strength Antibiotic Cream plus Pain Relief
68016-296-052021-01-29C16284748780-1ba0f9c33-167d-a910-e053-dadaa90a0b85Maximum Strength Antibiotic Cream plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-296-05Premier Value Max Strength Antibiotic plus pain relief1 in 1 BOXCREAM13
68016-296-05Premier Value Max Strength Antibiotic plus pain relief14 g in 1 TUBECREAM143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-296PREMIER VALUE MAX STRENGTH ANTIBIOTIC PLUS PAIN RELIEF (PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL) CREAM [PHARMACY VALUE ALLIANCE LLC]3Current NDC, Legacy NDC, 2 package rows20241222_9767821e-054b-3bd3-e053-2a95a90a4b0e.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 5 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ora Zen Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incabbf8c34-87cb-4366-9840-7264a5114b542026-03-11WarningsExact identifier
application number: M004
FM-24 FOAMINGCHLOROXYLENOLPeople's Janitorial Supplyb3c2e174-6099-ba08-e053-2995a90a72902026-03-10WarningsExact identifier
application number: M004
doubleantibioticointmentBACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC4eb5202e-8e5b-6d31-e054-00144ff88e882026-03-04WarningsExact identifier
application number: M004
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATUS PHARMACEUTICALS INCf64b3564-ea3c-4316-8f00-f92c08dcad352026-02-04WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCLVeridian Healthcared2374664-4668-4da5-9df7-44e6e421ad542026-01-29WarningsExact identifier
application number: M004
TheraCare Bacitracin ZincFIRST AID ANTIBIOTICVeridian Healthcare8217648d-5acb-4a1e-913f-43695f4e01ad2026-01-29WarningsExact identifier
application number: M004
Equate First Aid Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart907d44c5-cbd1-4d13-8c5c-c164f7a536e52026-01-29WarningsExact identifier
application number: M004
Natureplex Antibiotic plus PainBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex, LLC317acec2-8ab7-4b62-9d72-f98cab4f979c2026-01-29WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
application number: M004
A-Cute Derm AntisepationBENZETHONIUM CHLORIDEABBE Laboratories, Inc.d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec2026-01-24WarningsExact identifier
application number: M004
A-Cute Derm B-KleerBENZETHONIUM CHLORIDEABBE Laboratories, Inc.544333fe-6c3a-485b-b899-e029d97ea9622026-01-24WarningsExact identifier
application number: M004
Brace ReliefBENZOCAINEInfaLab,Incd7e57d67-4234-44a9-bbd3-72e99cd5bdb32026-01-16WarningsExact identifier
application number: M004
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
application number: M004
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsExact identifier
application number: M004
Hermon bed sore and pressure sore creamCALENDULA OFFICINALIS1X HPUS 1.5%Beautivity LLC48053402-b6c8-0443-e063-6294a90abce72026-01-10WarningsExact identifier
application number: M004
Walgreens Arthritis Pain Relief Capsaicin AnalgesicCAPSAICINWalgreen Companyda818dd5-bf64-46c2-a3ad-440b2874edbb2026-01-09WarningsExact identifier
application number: M004
QS Plus Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEABC Compounding Co., Inc.343f9139-47bc-44b0-9da1-d9d6f6334bc72026-01-06WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATEMelaleuca, Inc.65ae4607-689d-6056-e053-2a91aa0aff562025-12-31WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN9767821e-054b-3bd3-e053-2a95a90a4b0e3
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD9767821e-054b-3bd3-e053-2a95a90a4b0e3
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY9767821e-054b-3bd3-e053-2a95a90a4b0e3
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY9767821e-054b-3bd3-e053-2a95a90a4b0e3
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY9767821e-054b-3bd3-e053-2a95a90a4b0e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68016-296-05680160296051 TUBE in 1 BOX (68016-296-05) / 14 g in 1 TUBE1 tube2019-09-22NoNoCurrent