FDA.reportPublic FDA data

Extra Strength Sinus Relief Nasal Decongestant

Product NDC
70000-0132
11-digit product format
700000132
Labeler code
70000
Product ID
70000-0132_411c9eb3-fe39-f3db-e063-6394a90a82df
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
CARDINAL HEALTH
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-06
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
Extra Strength Sinus Relief Nasal Decongestant
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
0d8a009c-30b5-4f12-90bd-f8aa1110243fAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0132-1Extra Strength Sinus Relief Nasal Decongestant30 mL in 1 BOTTLE, SPRAYSPRAY307
70000-0132-1Extra Strength Sinus Relief Nasal Decongestant1 in 1 CARTONSPRAY17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0132-1ML - Milliliter70000-0132be551b46-bca0-4602-bfc7-dfa37b7c955812018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0132EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [CARDINAL HEALTH]6Current NDC, Legacy NDC, 2 package rows20241122_0d8a009c-30b5-4f12-90bd-f8aa1110243f.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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACKACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLWAL-MART STORES INC888bd90a-a059-4814-bd65-6b735ecfaf3a2026-08-31WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime and NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger49a98411-aa5a-6de3-e063-6294a90a148f2026-08-31WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDESixarp, LLC5a5a6917-9fb5-e6ca-e063-6394a90af9dc2026-08-31WarningsExact identifier
application number: M012
Zicam Intense Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.d916f7ff-84b7-57ef-e053-2995a90a3efa2026-08-31WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-31WarningsExact identifier
application number: M012
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLSixarp, LLC5a5e2458-bab0-4931-e063-6394a90ad6062026-08-31WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
application number: M012
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
application number: M012
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSN0d8a009c-30b5-4f12-90bd-f8aa1110243f7
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD0d8a009c-30b5-4f12-90bd-f8aa1110243f7
1087043phenylephrine hydrochloride 1 % Nasal SpraySY0d8a009c-30b5-4f12-90bd-f8aa1110243f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0132-1700000132011 BOTTLE, SPRAY in 1 CARTON (70000-0132-1) / 30 mL in 1 BOTTLE, SPRAY2017-06-060000-00-00NoNoCurrent