FDA.reportPublic FDA data

S2

Product NDC
0487-5901
11-digit product format
004875901
Labeler code
0487
Product ID
0487-5901_495453e6-2060-edaa-e063-6394a90a8a5d
Type
HUMAN OTC DRUG
Nonproprietary name
racepinephrine hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
Substance
RACEPINEPHRINE HYDROCHLORIDE
Active strength
11.25 mg/.5mL
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
S2
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RACEPINEPHRINE HYDROCHLORIDE11.25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
336096P2WEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310133Internal RxNorm lookup
863968Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd1b35c7-b23b-4b95-8162-df3d263fe32eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0487-5901-99S230 in 1 CARTONSOLUTION3012
0487-5901-99S21 in 1 POUCHSOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-5901-02EA - Each0487-5901e4fa89c2-def9-4c41-9c97-ccaf02f5b5cf12012-07-24
0487-5901-10EA - Each0487-59014e462d6e-f2d0-4ea7-bcfa-2073e6f5109f12013-02-13
0487-5901-99EA - Each0487-5901530e7c42-5bd7-483e-96d6-682b76349b3312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RACEPINEPHRINE HYDROCHLORIDEACTIVE INGREDIENT336096P2WES2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7
RACEPINEPHRINEACTIVE MOIETYGR0L9S3J0FS2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RS2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPS2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KS2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7
WATERINACTIVE INGREDIENT059QF0KO0RS2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-5901S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]11Current NDC, Legacy NDC, 2 package rows20241222_dd1b35c7-b23b-4b95-8162-df3d263fe32e.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 83 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid GelsACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.20ae92d9-fbc6-5b7a-e063-6294a90a15c32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51c44970-06e5-082e-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.54236151-37db-0b5a-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.52542774-fd05-640c-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dca689-e4a0-5526-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f2d18f6-935f-9215-e053-2a91aa0aedd32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6fb28fa1-ebbb-64bf-e053-2991aa0a1de42025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5213ca7f-5a78-6471-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f7ba256-ed14-5fe0-e053-2a91aa0aacc12025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.6f7bf92d-4aaf-86e0-e053-2991aa0a2d912025-12-04WarningsExact identifier
application number: M012
Afrin NoDrip Allergy Sinus NightOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.b023a571-7e54-7c63-e053-2a95a90a0f782025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEBayer HealthCare LLC.b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d2025-12-04WarningsExact identifier
application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3231869-8ddf-9d17-e053-2995a90ae6d52025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Multi Symptom FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ae7cf41e-b618-d6bb-e053-2a95a90a66922025-12-04WarningsExact identifier
application number: M012
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold, Cough and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.351d3c5c-05c8-921a-e063-6394a90abef92025-12-04WarningsExact identifier
application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e4f3f906-2252-21d1-e053-2a95a90a85df2025-12-04WarningsExact identifier
application number: M012
Afrin No Drip Pump Mist Bundle PackOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.16c52c79-baec-87db-e063-6294a90a3b3b2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310133racepinephrine 2.25 % Inhalation SolutionPSNdd1b35c7-b23b-4b95-8162-df3d263fe32e12
863968S-2, 2.25 % Inhalation SolutionPSNdd1b35c7-b23b-4b95-8162-df3d263fe32e12
863968racepinephrine 22.5 MG/ML Inhalation Solution [S-2]SBDdd1b35c7-b23b-4b95-8162-df3d263fe32e12
310133racepinephrine 22.5 MG/ML Inhalation SolutionSCDdd1b35c7-b23b-4b95-8162-df3d263fe32e12
310133racepinephrine 11.25 MG per 0.5 ML Inhalation SolutionSYdd1b35c7-b23b-4b95-8162-df3d263fe32e12
310133racepinephrine 2.25 % Inhalation SolutionSYdd1b35c7-b23b-4b95-8162-df3d263fe32e12
863968S-2 11.25 MG (racepinephrine hydrochloride 13.5 MG) per 0.5 ML Inhalation SolutionSYdd1b35c7-b23b-4b95-8162-df3d263fe32e12
863968S-2 2.25 % Inhalation SolutionSYdd1b35c7-b23b-4b95-8162-df3d263fe32e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-5901-990048759019930 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE30 pouch2000-01-010000-00-00NoNoCurrent