| 0067-8201-03 |
0067-8201 |
HUMAN OTC DRUG |
EXCEDRIN MIGRAINE |
Acetaminophen, Aspirin (NSAID) and Caffeine |
TABLET, FILM COATED |
ORAL |
20200325 |
N/A |
NDA |
NDA020802 |
Haleon US Holdings LLC |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
250 mg/1; 250 mg/1; 65 mg/1 |
1 BOTTLE in 1 CARTON (0067-8201-03) / 300 TABLET, FILM COATED in 1 BOTTLE |
| 67751-243-02 |
67751-243 |
HUMAN OTC DRUG |
Excedrin Migraine |
Acetaminophen, Aspirin, and Caffeine |
TABLET, FILM COATED |
ORAL |
20250313 |
N/A |
NDA |
NDA020802 |
Navajo Manufacturing Company Inc. |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
250 mg/1; 250 mg/1; 65 mg/1 |
2 POUCH in 1 CARTON (67751-243-02) / 2 TABLET, FILM COATED in 1 POUCH |
| 50269-158-01 |
50269-158 |
HUMAN OTC DRUG |
Excedrin Extra Strength Headache |
ACETAMINOPHEN, ASPIRIN, CAFFEINE |
TABLET, FILM COATED |
TOPICAL |
20240101 |
N/A |
NDA |
NDA020802 |
JC World Bell Wholesale Co., Inc |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
250 mg/1; 250 mg/1; 65 mg/1 |
25 POUCH in 1 BOX (50269-158-01) / 2 TABLET, FILM COATED in 1 POUCH |
| 50269-158-02 |
50269-158 |
HUMAN OTC DRUG |
Excedrin Extra Strength Headache |
ACETAMINOPHEN, ASPIRIN, CAFFEINE |
TABLET, FILM COATED |
TOPICAL |
20240101 |
N/A |
NDA |
NDA020802 |
JC World Bell Wholesale Co., Inc |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
250 mg/1; 250 mg/1; 65 mg/1 |
6 BLISTER PACK in 1 BOX (50269-158-02) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH |
| 50269-158-03 |
50269-158 |
HUMAN OTC DRUG |
Excedrin Extra Strength Headache |
ACETAMINOPHEN, ASPIRIN, CAFFEINE |
TABLET, FILM COATED |
TOPICAL |
20240101 |
N/A |
NDA |
NDA020802 |
JC World Bell Wholesale Co., Inc |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
250 mg/1; 250 mg/1; 65 mg/1 |
6 BLISTER PACK in 1 BOX (50269-158-03) / 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH |