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 58 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	bdc15c6f-73b4-488e-9134-e70565df71bb	2026-01-14	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCL 50 MG	DIPHENHYDRAMINE HCL	YYBA Corporation	4b012549-3958-43c1-9de7-897c5d8b20d3	2026-01-14	Warnings	Exact identifier application number: M012
Rite Aid Pharmacy congestion relief vaporizing steam	VAPORIZING STEAM	Rite Aid Pharmacy	0fb86b23-0313-8fd8-e063-6394a90a0f5f	2026-01-14	Warnings	Exact identifier application number: M012
Vapo Steam	VAPO STEAM	TOPCO ASSOCIATES, LLC	f216f69f-9580-25ac-e053-2995a90a5ac6	2026-01-14	Warnings	Exact identifier application number: M012
Leader Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	f27bf0b2-25cc-474c-ab6b-f227ed3525fa	2026-01-14	Warnings	Exact identifier application number: M012
Sinus PE plus Allergy	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Walgreen Company	a15979d4-87bf-42e7-b1f2-783496072141	2026-01-13	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	41f4bf6d-f83c-92e4-e063-6394a90aebab	2026-01-13	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e608643-1a74-b474-e063-6294a90ad2e0	2026-01-13	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	462cbf3d-51b1-dab9-e063-6394a90a70ba	2026-01-13	Warnings	Exact identifier application number: M012
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	4260542e-0980-4b0b-8177-1c9f2c53b5a6	2026-01-13	Warnings	Exact identifier application number: M012
Sweet Comfort	MENTHOL	Saje Natural Business Inc.	cf13cccd-723d-4d61-8a5e-b36281605cc7	2026-01-13	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Saje Natural Business Inc.	0320a305-99d1-4909-94cc-cd6509ecb948	2026-01-13	Warnings	Exact identifier application number: M012
Rolling Farmacy	MENTHOL	Saje Natural Business Inc.	a38765a9-22cd-4fc5-b5ab-c3cacbd52c74	2026-01-13	Warnings	Exact identifier application number: M012
Home Farmacy	MENTHOL	Saje Natural Business Inc.	add35d10-b27a-4ae8-b2de-8a285aaef155	2026-01-13	Warnings	Exact identifier application number: M012
Traveling Farmacy	MENTHOL	Saje Natural Business Inc.	5b70f5aa-ed36-65ab-e053-2a91aa0a6777	2026-01-13	Warnings	Exact identifier application number: M012
sinus plus allergy PE maximum strength	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	660d3c80-f249-41dd-aa93-a0b1e635ead0	2026-01-13	Warnings	Exact identifier application number: M012
Chest Comfort	MENTHOL	Saje Natural Business Inc.	8a3db169-6dd7-4dfd-8360-90315288f21b	2026-01-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	H E B	c9e977b6-fba6-49ea-9d80-b43b0842bbe1	2026-01-12	Warnings	Exact identifier application number: M012
PE Sinus Congestion	PHENYLEPHRINE HCL	Topco Associates, LLC	3264e291-7a0f-4e25-8390-ba441f22f650	2026-01-12	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	3f44cff6-240a-4a8d-aaa1-0da75a31a47b	2026-01-12	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