FDA.reportPublic FDA data

Recovery

Product NDC
70983-008
11-digit product format
709830008
Labeler code
70983
Product ID
70983-008_2e933d8b-a0cf-4e5e-8688-0237bd1425e1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-10-16
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
13 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 productproduct70983-008IInactivated by FDA2026-10-15
excluded packagepackage70983-00870983-008-01IInactivated by FDA2026-10-15

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-008-01Recovery1 in 1 BOXOINTMENT11
70983-008-01Recovery54.1 g in 1 CANISTEROINTMENT54.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-008RECOVERY (MENTHOL) OINTMENT [SAJE NATURAL BUSINESS INC.]1Legacy NDC, 2 package rows20161019_e67643b1-c7f6-423c-b925-466fad0cd5ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1813422menthol 1.27 % Topical OintmentPSNe67643b1-c7f6-423c-b925-466fad0cd5ac1
1813422menthol 0.0127 MG/MG Topical OintmentSCDe67643b1-c7f6-423c-b925-466fad0cd5ac1
1813422menthol 1.27 % Topical OintmentSYe67643b1-c7f6-423c-b925-466fad0cd5ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-008-01709830008011 CANISTER in 1 BOX (70983-008-01) > 54.1 g in 1 CANISTER1 canister2016-10-160000-00-00NoNoCurrent