sunmark tussin dm max

Product NDC
70677-0048
Requested package NDC
70677-0048-1
11-digit product format
706770048
Labeler code
70677
Product ID
70677-0048_7844b78a-2b52-4455-8573-65f119a75539
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-11-05
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/20mL; mg/20mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage70677-004870677-0048-1DDiscontinued 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 packagepackage70677-004870677-0048-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70677-004870677-0048-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0048-1ML - Milliliter70677-0048e8a66241-d658-4f5e-9d96-a8f2d43d605212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0048SUNMARK TUSSIN DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [STRATEGIC SOURCING SERVICES LLC]3Legacy NDC20241121_e90a7a6f-1773-4655-9fd0-2fa4b2bbf804.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-0048-1706770048011 BOTTLE in 1 CARTON (70677-0048-1) > 118 mL in 1 BOTTLE1 bottle2018-11-050000-00-00NoNoCurrent