FDA.reportPublic FDA data

Tylenol Sinus Severe

Product NDC
73097-014
11-digit product format
730970014
Labeler code
73097
Product ID
73097-014_518f815e-c2df-c43b-e063-6294a90a2161
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Savings Distributors LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tylenol Sinus Severe
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73097-014-022023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe
73097-014-402023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe
73097-014-502023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-014-02Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-40Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-40Tylenol Sinus Severe20 in 1 CARTONTABLET, COATED203
73097-014-50Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-50Tylenol Sinus Severe25 in 1 CARTONTABLET, COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-014TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SAVINGS DISTRIBUTORS LLC]1Current NDC, Legacy NDC, 5 package rows20190731_8eecb3f0-eb5e-e847-e053-2995a90a86bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73097-014-02730970014022 TABLET, COATED in 1 POUCH (73097-014-02) 2019-07-220000-00-00NoNoCurrent
73097-014-407309700144020 POUCH in 1 CARTON (73097-014-40) / 2 TABLET, COATED in 1 POUCH20 pouch2019-07-220000-00-00NoNoCurrent
73097-014-507309700145025 POUCH in 1 CARTON (73097-014-50) / 2 TABLET, COATED in 1 POUCH25 pouch2019-07-220000-00-00NoNoCurrent