Home NDC 49483-347 Comfort-Time
Product NDC 49483-347
11-digit product format 494830347
Labeler code 49483
Product ID 49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine, and Pyrilamine Maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Time Cap Labs, Inc
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-11-30
Substance ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength 500; 60; 15 mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Comfort-Time
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 60 mg/1 PYRILAMINE MALEATE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597298 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 49483-347-24 Comfort-Time 24 in 1 BLISTER PACK TABLET, FILM COATED 24 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 PYRILAMINE MALEATE ACTIVE INGREDIENT R35D29L3ZA COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 PYRILAMINE ACTIVE MOIETY HPE317O9TL COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-347 COMFORT-TIME (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET, FILM COATED [TIME CAP LABS, INC] 3 Current NDC, Legacy NDC, 1 package rows 20181215_e94a26a2-36e5-4e1e-aea1-24e035c98043.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 49483-347-24 49483034724 24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24) 2018-12-14 0000-00-00 No No Current