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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 3G6A5W338E, R35D29L3ZA |
| Rxcui | 1597298 |
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 |
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 |