Nasal Decongestant

Product NDC: 68210-4109
Requested package NDC: 68210-4109-2
11-digit product format: 682104109
Labeler code: 68210
Product ID: 68210-4109_eecaae45-890a-556f-e053-2a95a90a7e55
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-09-11
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [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	68210-4109	68210-4109-2	I	Inactivated by FDA		2026-10-15

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4109-2	Nasal Decongestant	225 in 1 BOTTLE	TABLET	225		7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4109	NASAL DECONGESTANT (PHENYLEPHRINE HCL) TABLET [SPIRIT PHARMACEUTICALS LLC]	7	Legacy NDC, 1 package rows	20241215_9e79cd1b-8b7c-46c2-a849-c7a3c6864e34.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	9e79cd1b-8b7c-46c2-a849-c7a3c6864e34	7
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	9e79cd1b-8b7c-46c2-a849-c7a3c6864e34	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4109-2	68210410902	225 TABLET in 1 BOTTLE (68210-4109-2)	225 tablet	2020-09-11	0000-00-00	No	No	Current