Maximum Strength Cold Tabs

Product NDC: 73598-1342
11-digit product format: 735981342
Labeler code: 73598
Product ID: 73598-1342_cf30ce4e-309a-4869-b469-ebfa2d28b80f
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form: CAPSULE, COATED
Route: ORAL
Labeler: JHK DBA American Safety & First Aid
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-26
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
GUAIFENESIN	100 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Field, Values table
Field	Values
Unii	362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73598-1342-1	Maximum Strength Cold Tabs	40 in 1 BOX	CAPSULE, COATED	40		1
73598-1342-1	Maximum Strength Cold Tabs	2 in 1 PACKET	CAPSULE, COATED	2		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73598-1342	MAXIMUM STRENGTH COLD TABS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, COATED [JHK DBA AMERICAN SAFETY & FIRST AID]	1	Current NDC, 2 package rows	20240731_e7d4fe9a-eb09-4266-90c9-290f61ce6ad0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73598-1342-1	73598134201	40 PACKET in 1 BOX (73598-1342-1) / 2 CAPSULE, COATED in 1 PACKET	40 packet	2024-06-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maximum Strength Cold Tabs	JHK DBA American Safety & First Aid \| LNK International, Inc.	2024-07-15	HUMAN OTC DRUG LABEL	1