No Drip Severe Congestion

Product NDC: 68016-309
11-digit product format: 680160309
Labeler code: 68016
Product ID: 68016-309_9a036ed6-9da7-4249-984c-ca7f44c1bf1e
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68016-309		I	Inactivated by FDA		2026-10-05
excluded package	package	68016-309	68016-309-03	I	Inactivated by FDA		2026-10-05

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 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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`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	68016-309-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68016-309-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68016-309-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68016-309-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68016-309-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68016-309-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68016-309-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68016-309-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68016-309-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68016-309-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68016-309-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68016-309-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68016-309-03	`9bebd1f3094a…`	`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 concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-309-03	2020-01-31	C162847	48780-1	9d75b9d1-29e2-f424-e053-dadaa90a57ce	Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-309-03	No Drip Severe CongestionPremier Value	1 in 1 CARTON	SPRAY	1		3
68016-309-03	No Drip Severe CongestionPremier Value	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-309-03	ML - Milliliter	68016-309	4b3b1d0b-4e89-421f-b5cf-29d08bc35fe9	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
EUCALYPTOL	INACTIVE INGREDIENT	RV6J6604TK	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-309	NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]	3	Legacy NDC, 2 package rows	20151014_5ab118a9-6501-40db-b038-b8234d98ac61.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	5ab118a9-6501-40db-b038-b8234d98ac61	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	5ab118a9-6501-40db-b038-b8234d98ac61	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	5ab118a9-6501-40db-b038-b8234d98ac61	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68016-309-03	68016030903	1 in 1 CARTON	Historical