FDA.reportPublic FDA data

Ultra Tuss DM

Product NDC
42213-161
Requested package NDC
42213-161-93
11-digit product format
422130161
Labeler code
42213
Product ID
42213-161_1074c6f9-8fb8-41d7-acaa-c8d5f4832369
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin dextromethorphan HBr
Dosage form
SYRUP
Route
ORAL
Labeler
Ultra Seal Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-06-19
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100 mg/5mL; mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42213-16142213-161-93DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42213-161-932023-12-05C16284748780-1f386c64a-1cd1-0266-e053-dadaa90a7c1aDrug Facts
42213-161-932023-01-30C16284748780-1f386c64a-1cd1-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602ULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42213-161-9342213016193474 mL in 1 BOTTLE (42213-161-93) 474 ml2012-06-190000-00-00NoNoCurrent