Nasal

Product NDC
79481-0101
11-digit product format
794810101
Labeler code
79481
Product ID
79481-0101_9e4a8087-f320-411b-966e-8c2a2c9af411
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Meijer, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-14
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
2026-12-31
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
Nasal
Listing expiration
2026-12-31

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
fea71cb9-e044-4729-ad26-1db0cdb9dd11Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0101-0Nasal30 mL in 1 BOTTLESPRAY302
79481-0101-0Nasal1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0101NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [MEIJER, INC.]2Current NDC, 2 package rows20240517_fea71cb9-e044-4729-ad26-1db0cdb9dd11.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 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLArmy & Air Force Exchange Service3d7109a5-4fe1-039b-e063-6394a90a13922025-08-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3d710deb-e42d-13eb-e063-6394a90a56e12025-08-28WarningsExact identifier
application number: M012
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
application number: M012
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
application number: M012
Adult Bisolvine AdultGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.8cde5e39-a338-45af-b847-3823627f29c52025-08-25WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
application number: M012
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLVerityRx9ca6c0f8-71d1-4953-8e98-3311c46640112025-08-22WarningsExact identifier
application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum StrengthPHENYLEPHRINE HCLSalado Sales, Inc.9056fa58-d6aa-4df5-97e0-9be3f2332f862025-08-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
application number: M012
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSNfea71cb9-e044-4729-ad26-1db0cdb9dd112
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCDfea71cb9-e044-4729-ad26-1db0cdb9dd112
1087043phenylephrine hydrochloride 1 % Nasal SpraySYfea71cb9-e044-4729-ad26-1db0cdb9dd112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0101-0794810101001 BOTTLE in 1 CARTON (79481-0101-0) / 30 mL in 1 BOTTLE1 bottle2024-05-14NoNoCurrent