FDA.reportPublic FDA data

Califlora

Product NDC
53499-5190
11-digit product format
534995190
Labeler code
53499
Product ID
53499-5190_b668a8ea-7d81-4d83-b3e4-ca4f5d2352e7
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula officinalis
Dosage form
GEL
Route
TOPICAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
2025-03-31
Substance
CALENDULA OFFICINALIS FLOWERING TOP
Active strength
1 [hp_X]/78g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53499-5190DDiscontinued by firm2026-08-17
excluded packagepackage53499-519053499-5190-4DDiscontinued by firm2026-08-17
excluded packagepackage53499-519053499-5190-8DDiscontinued by firm2026-08-17

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-5190-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-5190-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-5190-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-5190-8f5e01cc5f278…a2eaf40c39c3…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQCALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQCALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
WATERINACTIVE INGREDIENT059QF0KO0RCALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4
WITCH HAZELINACTIVE INGREDIENT101I4J0U34CALIFLORA (CALENDULA OFFICINALIS) GEL [NATURES WAY HOLDING CO.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-5190-4534995190041 TUBE in 1 CARTON (53499-5190-4) > 28 g in 1 TUBE1 tube2006-01-010000-00-00NoNoCurrent
53499-5190-8534995190081 TUBE in 1 CARTON (53499-5190-8) > 78 g in 1 TUBE1 tube2006-01-010000-00-00NoNoCurrent