PRAX

Product NDC
50268-682
11-digit product format
502680682
Labeler code
50268
Product ID
50268-682_47fbf804-a248-931b-e063-6294a90abc2b
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
AvPAK
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-11
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5
Rxcui1246075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-682-15PRAX237 mL in 1 BOTTLELOTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-682-15ML - Milliliter50268-6822eb1467f-6e41-4a05-bda9-dc00f6d1590f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-682PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [AVPAK]3Current NDC, Legacy NDC, 1 package rows20240308_dc646399-91ba-5cc1-e053-2a95a90a4f9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSNdc646399-91ba-5cc1-e053-2a95a90a4f9c4
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCDdc646399-91ba-5cc1-e053-2a95a90a4f9c4
1246075pramoxine hydrochloride 1 % Topical LotionSYdc646399-91ba-5cc1-e053-2a95a90a4f9c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-682-1550268068215237 mL in 1 BOTTLE (50268-682-15) 237 ml2022-04-110000-00-00NoNoCurrent