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 153 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDabur India Limited22916978-303d-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M012
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
application number: M012
Leader Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader25609b66-047c-46e7-bc95-20eb8e6c96172024-09-20WarningsExact identifier
application number: M012
equaline nasalPHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI67fdd277-7a7a-4404-8ca2-39802c46405f2024-09-20WarningsExact identifier
application number: M012
equaline tussinDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI8bc7fa7c-d565-48c9-9808-1042c3e9d4282024-09-20WarningsExact identifier
application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
application number: M012
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsExact identifier
application number: M012
Good Sense Nasal FourPHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company930469c1-384c-4440-b3e6-9dcd674871c42024-09-19WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC89272d2d-5533-4ae8-865b-cb204cec6d652024-09-17WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC5791c1c7-f614-4940-a45a-6291742e1e222024-09-17WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway2affd44d-2125-4a1f-919c-c082e7644ea82024-09-17WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSYACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINEAdvanced Rx LLCfa1a4d86-87bb-0c50-e053-6394a90a56e22024-09-13WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOMACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAdvanced Rx LLCfa1b60b1-49cb-1211-e053-6394a90a0a462024-09-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEWalgreen Company8db7df1c-46b5-49bd-9002-50b12d58001a2024-09-13WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1bdd7f8a-93ce-5309-e063-6294a90a91f02024-09-12WarningsExact 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