FDA.reportPublic FDA data

Mucus Relief Sinus Severe Congestion Relief

Product NDC
63868-722
11-digit product format
638680722
Labeler code
63868
Product ID
63868-722_284bee95-f715-99d1-e063-6394a90a62a8
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-10
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief Sinus Severe Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1243679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-722-20Mucus Relief Sinus Severe Congestion Relief10 in 1 BLISTER PACKTABLET, COATED104
63868-722-20Mucus Relief Sinus Severe Congestion Relief2 in 1 CARTONTABLET, COATED24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-722-20EA - Each63868-7224a64536e-b5c1-445a-ae50-b4679581c6f312022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-722MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]4Current NDC, Legacy NDC, 2 package rows20241204_0ea270b7-9c28-49fb-9615-c4afdbdbc8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN0ea270b7-9c28-49fb-9615-c4afdbdbc8f14
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD0ea270b7-9c28-49fb-9615-c4afdbdbc8f14
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY0ea270b7-9c28-49fb-9615-c4afdbdbc8f14
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY0ea270b7-9c28-49fb-9615-c4afdbdbc8f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-722-20638680722202 BLISTER PACK in 1 CARTON (63868-722-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-06-100000-00-00NoNoCurrent