sunmark

Product NDC
49348-690
11-digit product format
493480690
Labeler code
49348
Product ID
49348-690_936c668e-6f45-421f-83e6-ea942ed0bc02
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Strategic Sourcing Services 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 productproduct49348-690DDiscontinued by firm2026-10-16
excluded packagepackage49348-69049348-690-69DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-690-69GM - Gram49348-690f35ef848-344e-4928-b1b7-89b64563028112013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
NeomycinACTIVE MOIETYI16QD7X297SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KSUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
PRAMOXINEACTIVE MOIETY068X84E056SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPSUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1
waterINACTIVE INGREDIENT059QF0KO0RSUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-690SUNMARK ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [STRATEGIC SOURCING SERVICES LLC]3Legacy NDC20241006_9b1d5d4a-136d-42fa-9f51-3093a05ca65e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-690-69493480690691 TUBE in 1 CARTON (49348-690-69) > 14.2 g in 1 TUBE1 tube2013-02-130000-00-00NoNoCurrent