Miami Beach

Product NDC
58443-0255
11-digit product format
584430255
Labeler code
58443
Product ID
58443-0255_9c5a0b7d-ec25-ef9b-e053-2995a90a1824
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-09
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0255-32024-05-02C16284748780-1f386c649-b4a2-0266-e053-dadaa90a7c1a677acb24-0e17-6c1e-e053-2a91aa0a7a2b
58443-0255-32023-01-30C16284748780-1f386c649-b4a2-0266-e053-dadaa90a7c1a677acb24-0e17-6c1e-e053-2a91aa0a7a2b

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0255-358443025503118 mL in 1 TUBE (58443-0255-3) 118 ml2018-03-090000-00-00NoNoCurrent