FDA.reportPublic FDA data

AQUACOOL RED 500

Product NDC
70759-0007
11-digit product format
707590007
Labeler code
70759
Product ID
70759-0007_363dbb18-7e84-0255-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Pharmanuco
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-04
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70759-0007-12021-01-29C16284748780-1ba0f9c33-54fe-a910-e053-dadaa90a0b85Drug Facts
70759-0007-22021-01-29C16284748780-1ba0f9c33-54fe-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70759-0007-1AQUACOOL RED 500120 mL in 1 BOTTLE, PUMPGEL1203
70759-0007-2AQUACOOL RED 500500 mL in 1 BOTTLE, PUMPGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70759-0007AQUACOOL RED 500 (MENTHOL) GEL [PHARMANUCO]3Legacy NDC, 2 package rows20160627_35fbc9b0-e466-5717-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259150menthol 3 % Topical GelPSN35fbc9b0-e466-5717-e054-00144ff8d46c3
259150menthol 0.03 MG/MG Topical GelSCD35fbc9b0-e466-5717-e054-00144ff8d46c3
259150menthol 3 % Topical GelSY35fbc9b0-e466-5717-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70759-0007-170759000701120 mL in 1 BOTTLE, PUMP120 mlHistorical
70759-0007-270759000702500 mL in 1 BOTTLE, PUMP500 mlHistorical