MULTI-SYMPTOM DAYTIME

Product NDC: 68210-4134
Requested package NDC: 68210-4134-1
11-digit product format: 682104134
Labeler code: 68210
Product ID: 68210-4134_ee8bbc19-04e2-21ba-e053-2995a90a0faf
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-04-28
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68210-4134	68210-4134-1	I	Inactivated by FDA		2026-10-15

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
68210-4134-1	MULTI-SYMPTOM DAYTIME	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		5
68210-4134-1	MULTI-SYMPTOM DAYTIME	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4134	MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 2 package rows	20241215_d642c0b0-baa0-4c3e-8b1d-cfe3b73382da.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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	d642c0b0-baa0-4c3e-8b1d-cfe3b73382da	5
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	d642c0b0-baa0-4c3e-8b1d-cfe3b73382da	5
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	d642c0b0-baa0-4c3e-8b1d-cfe3b73382da	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4134-1	68210413401	1 BLISTER PACK in 1 CARTON (68210-4134-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2021-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF	SPIRIT PHARMACEUTICALS LLC	2024-12-13	HUMAN OTC DRUG LABEL	5