FDA.reportPublic FDA data

CareOne Fast Acting Nasal

Product NDC
41520-729
11-digit product format
415200729
Labeler code
41520
Product ID
41520-729_7fcebb5e-18c3-44a7-b84d-657d42f941f5
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-30
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
CareOne Fast Acting Nasal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087043Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-729-10CareOne Fast Acting Nasal1 in 1 CARTONSPRAY15
41520-729-10CareOne Fast Acting Nasal30 mL in 1 BOTTLESPRAY305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-729CAREONE FAST ACTING NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 2 package rows20241103_95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5.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 125 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
application number: M012
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
application number: M012
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, EqualineLEVMETAMFETAMINESupervalu Inc.44f72f34-d0b8-421f-b240-86286de874cf2024-12-20WarningsExact identifier
application number: M012
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012
Vaporising Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILNew Pride Corpf66476d5-036b-0b1c-e053-2a95a90a0a072024-12-19WarningsExact identifier
application number: M012
Chest Rub Vaporizing ActionMENTHOL AND CAMPHOR AND EUCALYPTUS OILSinghfam Corporationc6ea663a-9c4f-4d1a-a937-002806a8530a2024-12-19WarningsExact identifier
application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTIONCAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUSSinghfam Corporationf1e4caee-b50e-a0a6-e053-2a95a90aadce2024-12-19WarningsExact identifier
application number: M012
Leader Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)LEADER/Cardinal Health 110, Inc.ae580e6c-2efd-c788-e053-2995a90a33602024-12-19WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILJell Pharmaceuticals Pvt Ltd.d80b9cc1-55f5-76d5-e053-2995a90aa9672024-12-19WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILHome Smart Productsacab200e-48bd-69e1-e053-2995a90afde02024-12-19WarningsExact identifier
application number: M012
Halls MENTHO-LYPTUSMENTHOLMondelez Global LLCff21cf0e-9811-4819-bdfc-17a950e9b1142024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
application number: M012
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
application number: M012
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
application number: M012
Maximum strength Tussnex FM DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGuardian Drug Company0bae53e3-9661-4bc6-9fcc-da7fa131b0342024-12-19WarningsExact identifier
application number: M012
Vicks Vaposteam LavenderCAMPHOR, (-)-Kaz USA, Inc03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa92024-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSN95b22dce-ef54-4ab5-9cc3-0e1cefa09ec55
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD95b22dce-ef54-4ab5-9cc3-0e1cefa09ec55
1087043phenylephrine hydrochloride 1 % Nasal SpraySY95b22dce-ef54-4ab5-9cc3-0e1cefa09ec55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-729-10415200729101 BOTTLE in 1 CARTON (41520-729-10) / 30 mL in 1 BOTTLE1 bottle2016-11-300000-00-00NoNoCurrent