No Drip

Product NDC
68016-308
11-digit product format
680160308
Labeler code
68016
Product ID
68016-308_55158443-c286-4ab5-ab0a-147ab9d68385
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl Nasal Solution
Dosage form
SPRAY
Route
NASAL
Labeler
Chain Drug Consortium
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-04
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-308IInactivated by FDA2026-10-05
excluded packagepackage68016-30868016-308-03IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-308-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-308-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-308-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-308-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-308-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-308-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-308-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-308-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-308-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-308-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-308-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-308-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68016-308-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68016-308-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68016-308-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-308-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-308-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-308-03bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68016-308-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68016-308-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-308-039bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-308-032020-01-31C16284748780-19d75b9d0-7ae9-f424-e053-dadaa90a57ceNasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-308-03No DripPremier Value1 in 1 CARTONSPRAY12
68016-308-03No DripPremier Value30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-308-03ML - Milliliter68016-308bf28afaa-8fb7-4fa5-9811-d966ad919e3512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2
WATERINACTIVE INGREDIENT059QF0KO0RNO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-308NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2Legacy NDC, 2 package rows20151014_4e1f4180-5cf8-48a0-a01f-77cd4574e2a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN4e1f4180-5cf8-48a0-a01f-77cd4574e2a92
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4e1f4180-5cf8-48a0-a01f-77cd4574e2a92
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY4e1f4180-5cf8-48a0-a01f-77cd4574e2a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-308-03680160308031 in 1 CARTONHistorical