Numbing cream

Product NDC
85284-008
11-digit product format
852840008
Labeler code
85284
Product ID
85284-008_3c404ff7-8b89-9f6b-e063-6294a90a2d91
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
BLOOMWELL GARDENS LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-13
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Numbing cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5
Rxcui1052684

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
85284-008-01Numbing cream50 g in 1 BOTTLECREAM501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052684pramoxine HCl 1 % Topical CreamPSN3c404ff7-8b88-9f6b-e063-6294a90a2d911
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD3c404ff7-8b88-9f6b-e063-6294a90a2d911
1052684pramoxine hydrochloride 1 % Topical CreamSY3c404ff7-8b88-9f6b-e063-6294a90a2d911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85284-008-018528400080150 g in 1 BOTTLE (85284-008-01) 50 g2025-08-13NoNoCurrent