FDA.reportPublic FDA data

Rolaids Advanced Softchews Mixed Berry

Product NDC
41167-1043
Requested package NDC
41167-1043-5
11-digit product format
411671043
Labeler code
41167
Product ID
41167-1043_d86a5a61-dc30-4bb3-80ae-3b3d6418b226
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate, Dimethicone and Magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chattem, Inc.
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
1330 mg/1; mg/1; 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 packagepackage41167-104341167-1043-5DDiscontinued by firm2026-10-12

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 · 1 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 packagepackage41167-104341167-1043-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-1043ROLAIDS ADVANCED SOFTCHEWS MIXED BERRY (CALCIUM CARBONATE, DIMETHICONE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]6Legacy NDC20250507_f4fef54e-610d-4563-afeb-002513a1d39b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41167-1043-54116710430528 TABLET, CHEWABLE in 1 BAG (41167-1043-5) 2019-03-010000-00-00NoNoCurrent