burts bees throat soothing

Product NDC
0113-8004
Requested package NDC
0113-8004-22
11-digit product format
001138004
Labeler code
0113
Product ID
0113-8004_b4ba13c4-6e9c-4a2c-926e-e4f0ecfc6ccc
Type
HUMAN OTC DRUG
Nonproprietary name
pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-06
Marketing end
0000-00-00
Substance
PECTIN
Active strength
11 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-80040113-8004-22DDiscontinued by firm2026-10-05

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0113-80040113-8004-22DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-80040113-8004-22DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-8004-220011380042215 LOZENGE in 1 BAG (0113-8004-22) 15 lozenge2021-06-060000-00-00NoNoCurrent