FDA.reportPublic FDA data

Breezers

Product NDC
12546-150
11-digit product format
125460150
Labeler code
12546
Product ID
12546-150_66ab6e81-a377-4bce-82a8-e183a25ddcb5
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
Mondelez Global LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-11-21
Marketing end
0000-00-00
Substance
PECTIN
Active strength
7 mg/1
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 productproduct12546-150DDiscontinued by firm2026-08-17
excluded packagepackage12546-15012546-150-25DDiscontinued 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 · 24 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 packagepackage12546-150-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12546-150-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12546-150-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12546-150-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage12546-150-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage12546-150-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage12546-150-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage12546-150-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12546-150-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage12546-150-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage12546-150-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage12546-150-25557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12546-150-252021-12-20C16284748780-1ba0f9c33-3693-a910-e053-dadaa90a0b85Drug Facts
12546-150-252021-01-29C16284748780-1ba0f9c33-3693-a910-e053-dadaa90a0b85Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PECTINACTIVE INGREDIENT89NA02M4RXBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
PECTINACTIVE MOIETY89NA02M4RXBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7JBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554BREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBREEZERS TROPICAL CHILL (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1