FDA.reportPublic FDA data

Sunmark Nose

Product NDC
49348-197
Requested package NDC
49348-197-27
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-19749348-197-27DDiscontinued by firm2026-10-16

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-197-27ML - Milliliter49348-197672e1b1b-2547-49de-a1ac-de4968c92be212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK NOSE (PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCKESSON]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-197-27493480197271 BOTTLE, DROPPER in 1 CARTON (49348-197-27) > 30 mL in 1 BOTTLE, DROPPER2003-08-210000-00-00NoNoCurrent