FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-956-282025-05-09C16284748780-12cef2736-7465-d83d-e063-dadaa90ab31fSignature Care Original Nasal Spray 1oz
21130-956-282025-05-09C16284748780-12cef2736-7465-d83d-e063-dadaa90ab31fSignature Care Original Nasal Spray 1oz 76095
21130-956-282025-01-30C16284748780-12cef2736-7465-d83d-e063-dadaa90ab31fSignature Care Original Nasal Spray 1oz
21130-956-282025-01-30C16284748780-12cef2736-7465-d83d-e063-dadaa90ab31fSignature Care Original Nasal Spray 1oz 76095

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-956-28Signature Care Original30 mL in 1 BOTTLE, SPRAYSPRAY304
21130-956-28Signature Care Original1 in 1 CARTONSPRAY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-956SIGNATURE CARE ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAFEWAY, INC.]3Current NDC, 2 package rows20250511_f7ad687b-dcaf-928c-e053-6294a90a6abe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNf7ad687b-dcaf-928c-e053-6294a90a6abe4
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDf7ad687b-dcaf-928c-e053-6294a90a6abe4
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYf7ad687b-dcaf-928c-e053-6294a90a6abe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21130-956-28211300956281 BOTTLE, SPRAY in 1 CARTON (21130-956-28) / 30 mL in 1 BOTTLE, SPRAY2023-10-18NoNoHistorical