Nasal Decongestant PE

Product NDC
69168-272
11-digit product format
691680272
Labeler code
69168
Product ID
69168-272_d6f9b26d-57c2-492c-aafd-baf2f1ffd3e3
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine 10 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [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
Nasal Decongestant PE
Brand name suffix
Maximum Strength Non-Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1049182

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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-272-932020-03-13C16284748780-19d75b9d0-5080-f424-e053-dadaa90a57ceDrug Facts
69168-272-932020-03-13C16284748780-19d75b9d0-5080-f424-e053-dadaa90a57ceDrug Facts
69168-272-932020-01-31C16284748780-19d75b9d0-5080-f424-e053-dadaa90a57ceDrug Facts
69168-272-932020-01-31C16284748780-19d75b9d0-5080-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-272-17Nasal Decongestant PEMaximum Strength Non-Drowsy300 in 1 BOTTLETABLET30010
69168-272-82Nasal Decongestant PEMaximum Strength Non-Drowsy90 in 1 BOTTLETABLET9010
69168-272-93Nasal Decongestant PEMaximum Strength Non-Drowsy1 in 1 CARTONTABLET110
69168-272-93Nasal Decongestant PEMaximum Strength Non-Drowsy24 in 1 BLISTER PACKTABLET2410

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-272NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY (PHENYLEPHRINE 10 MG) TABLET [ALLEGIANT HEALTH]9Current NDC, Legacy NDC, 4 package rows20231114_7aef00df-816a-4ea2-a2ad-beed66dd2fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN7aef00df-816a-4ea2-a2ad-beed66dd2fe410
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD7aef00df-816a-4ea2-a2ad-beed66dd2fe410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-272-1769168027217300 TABLET in 1 BOTTLE (69168-272-17) 300 tablet2021-06-160000-00-00NoNoCurrent
69168-272-826916802728290 TABLET in 1 BOTTLE (69168-272-82) 90 tablet2022-05-180000-00-00NoNoCurrent
69168-272-93691680272931 BLISTER PACK in 1 CARTON (69168-272-93) / 24 TABLET in 1 BLISTER PACK1 blister pack2014-12-230000-00-00NoNoCurrent