Severe sinus Congestion Relief

Product NDC
41520-985
11-digit product format
415200985
Labeler code
41520
Product ID
41520-985_2778c533-445e-a395-e063-6394a90a51a3
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
FOODHOLD U.S.A., LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-06
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
Rxcui1656815

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-985-14Severe sinus Congestion Relief8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED83
41520-985-14Severe sinus Congestion Relief2 in 1 CARTONCAPSULE, LIQUID FILLED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-985SEVERE SINUS CONGESTION RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FOODHOLD U.S.A., LLC]3Current NDC, Legacy NDC, 2 package rows20241123_e173bec9-14df-4535-a023-47d8cda8d4ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNe173bec9-14df-4535-a023-47d8cda8d4ec3
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDe173bec9-14df-4535-a023-47d8cda8d4ec3
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYe173bec9-14df-4535-a023-47d8cda8d4ec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-985-14415200985142 BLISTER PACK in 1 CARTON (41520-985-14) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2016-10-060000-00-00NoNoCurrent