Device - NebuClear MD Hand-held Rubber Bulb Nebulizer

Product NDC
73117-509
11-digit product format
731170509
Labeler code
73117
Product ID
73117-509_5197a04f-a42a-7c51-e063-6394a90a9214
Type
HUMAN OTC DRUG
Nonproprietary name
Device - Hand-held Rubber Bulb Nebulizer
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Blue Echo Care LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-18
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
Device - NebuClear MD Hand-held Rubber Bulb Nebulizer
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43e0a646-be57-1024-e063-6394a90a43e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73117-509-01Device - NebuClear MD Hand-held Rubber Bulb Nebulizer1 mL in 1 BOTTLE, SPRAYSOLUTION14

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 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corp432a79a9-c69d-4514-894a-7832e1b745ef2025-12-04WarningsExact identifier
application number: M012
GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS69d16d25-b09b-430e-8e01-0962d840dc212025-12-04WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLH E B7c04ab14-af28-4598-90ef-56ac11902c7d2025-12-04WarningsExact identifier
application number: M012
Desgen PediatricDEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCLKramer Novis12425c1b-8bdc-446b-83dd-95e05a4d9b8c2025-12-04WarningsExact identifier
application number: M012
Presgen BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5befa829-32bd-4978-8a0e-1d6513ff37a42025-12-03WarningsExact identifier
application number: M012
TUSSLINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKramer Novis987e19a5-032f-44e9-b4c7-8a764d5026952025-12-03WarningsExact identifier
application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.450e8974-8ff8-4b82-e063-6394a90a93662025-12-03WarningsExact identifier
application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store Products, Inc.4510223f-1c88-2796-e063-6394a90a18ac2025-12-03WarningsExact identifier
application number: M012
Carolina Crud CrusherDEXTROMETHORPHAN HBR, GUAIFENESINWeeks & Leo Co., Inc.0b606683-7d68-cca5-e063-6394a90a6f582025-12-03WarningsExact identifier
application number: M012
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
application number: M012
ALA-HIST IRDEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.0d203b5c-8b10-428b-8703-17be6b4ce6eb2025-12-03WarningsExact identifier
application number: M012
ALAHIST DMDEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.fdaa062d-110e-798d-e053-6394a90a755c2025-12-03WarningsExact identifier
application number: M012
Alahist DPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.a1b8533a-ef8b-57cc-e053-2995a90a5d9e2025-12-03WarningsExact identifier
application number: M012
Alahist PEDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.ada2d582-5813-2029-e053-2a95a90ae5672025-12-03WarningsExact identifier
application number: M012
Benadryl Allergy Extra Strength Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC30aca3ab-b091-3939-e063-6294a90a98192025-12-03WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRL.N.K. International, Inc.9f2daffc-1904-4d64-9f84-689c88601e062025-12-03WarningsExact identifier
application number: M012
Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.d291faa9-894e-421c-8115-8a8c2a9371722025-12-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310133racepinephrine 2.25 % Inhalation SolutionPSN3598ac5b-29f9-f002-e063-6294a90a62cb7
310133racepinephrine 22.5 MG/ML Inhalation SolutionSCD3598ac5b-29f9-f002-e063-6294a90a62cb7
310133racepinephrine 11.25 MG per 0.5 ML Inhalation SolutionSY3598ac5b-29f9-f002-e063-6294a90a62cb7
310133racepinephrine 2.25 % Inhalation SolutionSY3598ac5b-29f9-f002-e063-6294a90a62cb7
310133racepinephrine 2.25 % Inhalation SolutionPSN51badd2f-4a43-3dbe-e063-6294a90a4bd12
310133racepinephrine 22.5 MG/ML Inhalation SolutionSCD51badd2f-4a43-3dbe-e063-6294a90a4bd12
310133racepinephrine 11.25 MG per 0.5 ML Inhalation SolutionSY51badd2f-4a43-3dbe-e063-6294a90a4bd12
310133racepinephrine 2.25 % Inhalation SolutionSY51badd2f-4a43-3dbe-e063-6294a90a4bd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73117-509-01731170509011 mL in 1 BOTTLE, SPRAY (73117-509-01) 1 ml2025-11-18NoNoCurrent