Sunmark Nose

Product NDC: 49348-197
11-digit product format: 493480197
Labeler code: 49348
Product ID: 49348-197_d3fc4610-3632-4408-bac8-14cfe80aac74
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: NASAL
Labeler: Strategic Sourcing Services LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2003-08-21
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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	49348-197		D	Discontinued by firm		2026-10-16
excluded package	package	49348-197	49348-197-27	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-197-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-197-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-197-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-197-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-197-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-197-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-197-27	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-197-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-197-27	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-197-27	ML - Milliliter	49348-197	672e1b1b-2547-49de-a1ac-de4968c92be2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-197-27	49348019727	1 BOTTLE, DROPPER in 1 CARTON (49348-197-27) > 30 mL in 1 BOTTLE, DROPPER	2003-08-21	0000-00-00	No	No	Current