FDA.reportPublic FDA data

INTEGRAL B Keep Calming Mist

Product NDC
71380-0010
Requested package NDC
71380-0010-1
11-digit product format
713800010
Labeler code
71380
Product ID
71380-0010_985e9848-0f04-1041-e053-2995a90acda2
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Nature4 co., Ltd.
Application
part347
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-10-01
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71380-001071380-0010-1DDiscontinued by firm2026-08-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71380-0010-171380001001120 mL in 1 BOTTLE, SPRAY (71380-0010-1) 120 ml2019-10-010000-00-00NoNoCurrent