Tussin CF

Product NDC
63868-244
Requested package NDC
63868-244-04
11-digit product format
638680244
Labeler code
63868
Product ID
63868-244_c2e6be8e-1f08-4bbe-a6f2-c5615e100918
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/10mL; mg/10mL; mg/10mL
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 packagepackage63868-24463868-244-04DDiscontinued 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 · 9 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63868-244-042023-05-11Drug Facts
63868-244-082023-05-11Drug Facts
63868-244-042023-01-30Drug Facts
63868-244-082023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-244-04ML - Milliliter63868-244e48ea45a-d30e-4e43-a13d-c0757ff3ef1a12015-04-03
63868-244-08ML - Milliliter63868-244152c4762-0abb-4c9b-a3bb-e6b93c8a221312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
SORBITOLINACTIVE INGREDIENT506T60A25RTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN CF NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-244-04638680244041 BOTTLE, PLASTIC in 1 BOX (63868-244-04) > 118 mL in 1 BOTTLE, PLASTIC2014-06-300000-00-00NoNoCurrent