Mucus Relief Cold and Flu All in One

Product NDC
63868-589
11-digit product format
638680589
Labeler code
63868
Product ID
63868-589_2435b3e0-536c-f685-e063-6394a90a6a77
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Marketing end
2027-01-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief Cold and Flu All in One

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1110988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-589-20Mucus Relief Cold and Flu All in One2 in 1 CARTONTABLET, COATED24
63868-589-20Mucus Relief Cold and Flu All in One10 in 1 BLISTER PACKTABLET, COATED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-589-20EA - Each63868-5898671f248-698d-48bb-adb9-af9d4342cdc612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-589MUCUS RELIEF COLD AND FLU ALL IN ONE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4Current NDC, Legacy NDC, 2 package rows20241013_ff433512-55b7-4fc9-8a55-aff5cbb749ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNff433512-55b7-4fc9-8a55-aff5cbb749ef4
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDff433512-55b7-4fc9-8a55-aff5cbb749ef4
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYff433512-55b7-4fc9-8a55-aff5cbb749ef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-589-20638680589202 BLISTER PACK in 1 CARTON (63868-589-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-12-082027-01-31NoNoCurrent