PSEUDO TIME PE

Product NDC
49483-234
11-digit product format
494830234
Labeler code
49483
Product ID
49483-234_7d0279a6-3a55-e7e4-e053-2a91aa0a1df7
Type
HUMAN OTC DRUG
Nonproprietary name
PHENYLEPHRINE HCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-05-14
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
PSEUDO TIME PE
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-234-00PSEUDO TIME PE100000 in 1 CARTONTABLET, FILM COATED1000002
49483-234-18PSEUDO TIME PE18 in 1 BLISTER PACKTABLET, FILM COATED182
49483-234-36PSEUDO TIME PE36 in 1 BLISTER PACKTABLET, FILM COATED362

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-234PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.]2Current NDC, Legacy NDC, 3 package rows20181218_3116f273-0517-4755-95cd-be3a7c0dd76b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN3116f273-0517-4755-95cd-be3a7c0dd76b2
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD3116f273-0517-4755-95cd-be3a7c0dd76b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-234-0049483023400100000 TABLET, FILM COATED in 1 CARTON (49483-234-00) 2018-12-140000-00-00NoNoCurrent
49483-234-184948302341818 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-18) 2018-12-140000-00-00NoNoCurrent
49483-234-364948302343636 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-36) 2018-12-140000-00-00NoNoCurrent