FDA.reportPublic FDA data

Nasal Decongestant PE

Product NDC
63868-144
11-digit product format
638680144
Labeler code
63868
Product ID
63868-144_d534021e-9167-4966-bd79-d13ee792282b
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-01-14
Marketing end
2027-11-30
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Decongestant PE
Brand name suffix
Non-Drowsy Maximum Strength

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-144-19Nasal Decongestant PENon-Drowsy Maximum Strength1 in 1 CARTONTABLET, FILM COATED118
63868-144-19Nasal Decongestant PENon-Drowsy Maximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1818
63868-144-37Nasal Decongestant PENon-Drowsy Maximum Strength2 in 1 CARTONTABLET, FILM COATED218
63868-144-37Nasal Decongestant PENon-Drowsy Maximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1818
63868-144-74Nasal Decongestant PENon-Drowsy Maximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1818
63868-144-74Nasal Decongestant PENon-Drowsy Maximum Strength4 in 1 CARTONTABLET, FILM COATED418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-144-19EA - Each63868-144b5927e77-46ef-4f74-8f8d-c3a856dd983312022-09-12
63868-144-37EA - Each63868-14427b2cccd-bdd5-4cd2-aac3-04c6f8c4c9ef12022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-144NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]17Current NDC, Legacy NDC, 6 package rows20250130_bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d18
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-144-19638680144191 BLISTER PACK in 1 CARTON (63868-144-19) / 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-01-142027-07-31NoNoCurrent
63868-144-37638680144372 BLISTER PACK in 1 CARTON (63868-144-37) / 18 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-01-142027-11-30NoNoCurrent
63868-144-74638680144744 BLISTER PACK in 1 CARTON (63868-144-74) > 18 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2005-01-142022-03-23NoNoCurrent