FDA.reportPublic FDA data

Severe Sinus Congestion and Pain

Product NDC
83059-0057
11-digit product format
830590057
Labeler code
83059
Product ID
83059-0057_4276cd88-1e20-408b-e063-6394a90ae904
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Shield Pharmaceuticals Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
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
Severe Sinus Congestion and Pain
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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0057-1Severe Sinus Congestion and Pain1 in 1 CARTONTABLET, COATED14
83059-0057-1Severe Sinus Congestion and Pain12 in 1 BLISTER PACKTABLET, COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83059-0057SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE) TABLET, COATED [SHIELD PHARMACEUTICALS CORP]3Current NDC, 2 package rows20241228_c296efd0-5030-4a26-a9b0-e66423d995dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNc296efd0-5030-4a26-a9b0-e66423d995dc4
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDc296efd0-5030-4a26-a9b0-e66423d995dc4
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYc296efd0-5030-4a26-a9b0-e66423d995dc4
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYc296efd0-5030-4a26-a9b0-e66423d995dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83059-0057-1830590057011 BLISTER PACK in 1 CARTON (83059-0057-1) / 12 TABLET, COATED in 1 BLISTER PACK1 blister pack2024-10-30NoNoCurrent