FDA.reportPublic FDA data

Premier Value

Product NDC
68016-076
11-digit product format
680160076
Labeler code
68016
Product ID
68016-076_d827202d-4e5a-4444-b8dd-fbacfc15d041
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-21
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
4 mg/g; [iU]/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-076IInactivated by FDA2026-09-14
excluded packagepackage68016-07668016-076-01IInactivated by FDA2026-09-14

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 · 4 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 packagepackage68016-076-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-076-01f5e01cc5f278…a2eaf40c39c3…

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
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
68016-076-012025-07-29C16284748780-13b156c62-2faa-fb37-e063-e6dba90a4e07Premier Value ® Antibiotic Plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-076-01Premier Value Antibiotic Plus Pain Relief1 in 1 CARTONCREAM13
68016-076-01Premier Value Antibiotic Plus Pain Relief14.2 g in 1 TUBECREAM14.23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
Pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
NeomycinACTIVE MOIETYI16QD7X297PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KPREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
PramoxineACTIVE MOIETY068X84E056PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1
WATERINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-076PREMIER VALUE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [PHARMACY VALUE ALLIANCE LLC]3Legacy NDC, 2 package rows20180305_8efaf795-14c8-4419-ba99-cb7e2e64cf8e.zip

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 CreamPSN8efaf795-14c8-4419-ba99-cb7e2e64cf8e3
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8efaf795-14c8-4419-ba99-cb7e2e64cf8e3
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY8efaf795-14c8-4419-ba99-cb7e2e64cf8e3
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY8efaf795-14c8-4419-ba99-cb7e2e64cf8e3
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY8efaf795-14c8-4419-ba99-cb7e2e64cf8e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-076-01680160076011 TUBE in 1 CARTON (68016-076-01) > 14.2 g in 1 TUBE1 tube2012-03-210000-00-00NoNoCurrent