Indulgence/ProPower

Product NDC
61307-213
11-digit product format
613070213
Labeler code
61307
Product ID
61307-213_f1e9f9e2-fcf0-61d2-e053-2995a90af59d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
U S Chemical Corporation
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-01-30
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
3 mg/L
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct61307-213EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61307-21361307-213-41EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61307-213-102022-01-31US Chem F213F
61307-213-412022-01-31US Chem F213F
61307-213-102022-01-28US Chem F213F
61307-213-412022-01-28US Chem F213F
61307-213-412020-03-24US Chem F213F
61307-213-412020-01-31US Chem F213F

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61307-213-10613070213101 L in 1 BAG (61307-213-10) 1 l2017-01-300000-00-00NoNoCurrent
61307-213-41613070213411 L in 1 BAG (61307-213-41) 1 l2017-01-300000-00-00NoNoCurrent