Signature Care Original

Product NDC: 21130-956
11-digit product format: 211300956
Labeler code: 21130
Product ID: 21130-956_414e52e3-3410-9d29-e063-6294a90af9cc
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: SAFEWAY, INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-18
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21130-956-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21130-956-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21130-956-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21130-956-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21130-956-28	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21130-956-28	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21130-956-28	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Signature Care Original
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f7ad687b-dcaf-928c-e053-6294a90a6abe	Available on FDA.report

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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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#

Effective, Related label table
Effective	Related label
2025-05-09	Signature Care Original Nasal Spray 1oz
2025-05-09	Signature Care Original Nasal Spray 1oz 76095
2025-01-30	Signature Care Original Nasal Spray 1oz
2025-01-30	Signature Care Original Nasal Spray 1oz 76095

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-956-28	Signature Care Original	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		4
21130-956-28	Signature Care Original	1 in 1 CARTON	SPRAY	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-956	SIGNATURE CARE ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAFEWAY, INC.]	3	Current NDC, 2 package rows	20250511_f7ad687b-dcaf-928c-e053-6294a90a6abe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 61 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Berkley and Jensen Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	c15b97a8-968f-4d38-905e-863e9fd16ce6	2026-01-06	Warnings	Exact identifier application number: M012
Complete Allergy Medicine	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	c0f5c8ca-b187-40bf-9245-6a29f1c32c97	2026-01-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	c5776b1e-9f72-4a6a-9961-8ac8e05b3249	2026-01-06	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	b9215a5e-3be8-44fd-9189-50dab760869c	2026-01-06	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Major Pharmaceuticals	f81efbf4-204b-45be-ae32-910d9e4ae4aa	2026-01-06	Warnings	Exact identifier application number: M012
SINUS AND NASAL DECONGESTANT	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d7646859-f996-46cd-a0b9-56b860f60901	2026-01-05	Warnings	Exact identifier application number: M012
HyVee Cough Drops Honey Lemon	MENTHOL	HY-VEE, INC	47a71cdf-856d-9ecd-e063-6294a90a70c6	2026-01-05	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Oncor Pharmaceuticals	fd35036c-b722-48a3-85fd-60471beb6e74	2026-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals,Inc.	3c323dc8-f734-b44c-e063-6394a90a6184	2026-01-05	Warnings	Exact identifier application number: M012
Congestion and Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f43d97b1-aeb9-4ca5-8909-b28e7bf764f5	2026-01-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	6bd2b8fd-2023-413b-8988-a47d2058dc85	2026-01-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	WinCo Foods, LLC	4c1046df-53a6-4219-83ac-bbf5cf4db9c8	2026-01-05	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	80323208-9ba5-432b-a8a0-0c0b51e67145	2026-01-05	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain PE Maximum Strength	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Rite Aid Corporation	347868e4-0182-4e16-895c-ec269895c57c	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	c5b11a9c-6d93-4772-93c2-1ef5c5647016	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Honey Lemon	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	fae96736-1453-42fe-8158-cde770b23165	2026-01-02	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd	2026-01-02	Warnings	Exact identifier application number: M012
Reliable-1 Tussin	GUAIFENESIN	RELIABLE 1 LABORATORIES LLC	2a33ff82-49df-7aaa-e063-6294a90a1281	2026-01-02	Warnings	Exact identifier application number: M012
Tussin DMMax	DEXTROMETHORPHAN HBR, GUAIFENESIN	RELIABLE 1 LABORATORIES LLC	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	2026-01-02	Warnings	Exact identifier application number: M012
Severe Sinus Pain and Congestion Daytime	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	2026-01-02	Warnings	Exact identifier application number: M012

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	f7ad687b-dcaf-928c-e053-6294a90a6abe	4
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	f7ad687b-dcaf-928c-e053-6294a90a6abe	4
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	f7ad687b-dcaf-928c-e053-6294a90a6abe	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
21130-956-28	21130095628	1 BOTTLE, SPRAY in 1 CARTON (21130-956-28) / 30 mL in 1 BOTTLE, SPRAY	2023-10-18	No	No	Current