Unishield Cough and Cold

Product NDC: 49314-4358
11-digit product format: 493144358
Labeler code: 49314
Product ID: 49314-4358_e6ff40aa-f5fa-a5bd-e053-2995a90adabd
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unishield
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-09-26
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49314-4358		I	Inactivated by FDA		2026-10-05
excluded package	package	49314-4358	49314-4358-0	I	Inactivated by FDA		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49314-4358-0	Unishield Cough and Cold	2 in 1 PACKET	TABLET, FILM COATED	2		2
49314-4358-0	Unishield Cough and Cold	40 in 1 BOX	TABLET, FILM COATED	40		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49314-4358	UNISHIELD COUGH AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN) TABLET, FILM COATED [UNISHIELD]	2	Legacy NDC, 2 package rows	20240118_e6ff40aa-f5f9-a5bd-e053-2995a90adabd.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098435	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	e6ff40aa-f5f9-a5bd-e053-2995a90adabd	2
1098435	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	e6ff40aa-f5f9-a5bd-e053-2995a90adabd	2
1098435	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	e6ff40aa-f5f9-a5bd-e053-2995a90adabd	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49314-4358-0	49314435800	40 PACKET in 1 BOX (49314-4358-0) > 2 TABLET, FILM COATED in 1 PACKET	40 packet	2022-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Unishield Cough & Cold	Unishield \| Unifirst First Aid Corporation	2024-01-17	HUMAN OTC DRUG LABEL	2