Sound Body 12 Hour Nasal

Product NDC: 23558-5120
11-digit product format: 235585120
Labeler code: 23558
Product ID: 23558-5120_988b789b-822f-462a-9ea3-20035d78107e
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Lee Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2008-01-31
Marketing end: 0000-00-00
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: 50 mg/100mL
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	23558-5120		I	Inactivated by FDA		2026-10-05
excluded package	package	23558-5120	23558-5120-0	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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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	23558-5120-0	`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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
23558-5120-0	2020-01-31	C162847	48780-1	9d75b9d0-96fd-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23558-5120-0	Sound Body 12 Hour NasalOriginal	1 in 1 CARTON	SPRAY	1		4
23558-5120-1	Sound Body 12 Hour NasalOriginal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
EDETATE DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8NLQ36F6MM	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23558-5120	SOUND BODY 12 HOUR NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LEE PHARMACEUTICALS]	4	Legacy NDC, 2 package rows	20130621_1915ad26-8b4d-4540-8795-ec7538bb60ee.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	1915ad26-8b4d-4540-8795-ec7538bb60ee	4
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	1915ad26-8b4d-4540-8795-ec7538bb60ee	4
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	1915ad26-8b4d-4540-8795-ec7538bb60ee	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
23558-5120-0	23558512000	1 in 1 CARTON		Historical
23558-5120-1	23558512001	30 mL in 1 BOTTLE, SPRAY	30 ml	Historical