Home NDC 49483-234 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PSEUDO TIME PE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049182 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-234-00 PSEUDO TIME PE 100000 in 1 CARTON TABLET, FILM COATED 100000 2 49483-234-18 PSEUDO TIME PE 18 in 1 BLISTER PACK TABLET, FILM COATED 18 2 49483-234-36 PSEUDO TIME PE 36 in 1 BLISTER PACK TABLET, FILM COATED 36 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 MAGNESIUM SILICATE INACTIVE INGREDIENT 9B9691B2N9 PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-234 PSEUDO TIME PE (PHENYLEPHRINE HCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20181218_3116f273-0517-4755-95cd-be3a7c0dd76b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-234-00 49483023400 100000 TABLET, FILM COATED in 1 CARTON (49483-234-00) 2018-12-14 0000-00-00 No No Current 49483-234-18 49483023418 18 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-18) 2018-12-14 0000-00-00 No No Current 49483-234-36 49483023436 36 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-36) 2018-12-14 0000-00-00 No No Current