FDA.reportPublic FDA data

Sinus Congestion and Pain

Product NDC
49035-527
11-digit product format
490350527
Labeler code
49035
Product ID
49035-527_dbfccbf6-2f75-4679-824d-f8cdfd7b7319
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-08-06
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
Sinus Congestion and Pain
Brand name suffix
Severe
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-527-08Sinus Congestion and PainSevere12 in 1 BLISTER PACKTABLET, FILM COATED1219
49035-527-08Sinus Congestion and PainSevere2 in 1 CARTONTABLET, FILM COATED219
49035-527-42Sinus Congestion and PainSevere12 in 1 BLISTER PACKTABLET, FILM COATED1219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-527-08EA - Each49035-5271bfb9649-66c8-411b-8590-9b64f2ccf3bb12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
GUAIFENESINACTIVE INGREDIENT495W7451VQSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
GUAIFENESINACTIVE MOIETY495W7451VQSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1USINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-527SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]18Current NDC, Legacy NDC, 3 package rows20250108_f51d1d52-39c2-4259-8b30-f9ac21edb265.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf51d1d52-39c2-4259-8b30-f9ac21edb26519
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf51d1d52-39c2-4259-8b30-f9ac21edb26519
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf51d1d52-39c2-4259-8b30-f9ac21edb26519
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf51d1d52-39c2-4259-8b30-f9ac21edb26519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-527-08490350527082 BLISTER PACK in 1 CARTON (49035-527-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-060000-00-00NoNoCurrent
49035-527-424903505274212 TABLET, FILM COATED in 1 BLISTER PACK (49035-527-42) 2005-08-060000-00-00NoNoCurrent