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
Ingredient	Strength
RACEPINEPHRINE HYDROCHLORIDE	11.25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
336096P2WE	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
43e0a646-be57-1024-e063-6394a90a43e4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73117-509-01	Device - NebuClear MD Hand-held Rubber Bulb Nebulizer	1 mL in 1 BOTTLE, SPRAY	SOLUTION	1		4

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 130 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola USA Inc.	ee4733b5-6e5a-438a-97da-110f3ef6c809	2024-12-10	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola USA Inc.	f62fcc38-2d43-40b3-841f-c8eea9ebd1e1	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	8a6db093-7e52-443f-8dd6-94867606fef8	2024-12-10	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola USA Inc.	5885343e-4a6e-44f7-87a4-d52599156197	2024-12-10	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola USA Inc.	0baf383c-886d-47ca-8a6d-221298c79446	2024-12-10	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Best Choice (Valu Merchandisers Company)	539b8972-2a46-468e-ad27-6672d746feb7	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	db2ab9be-507d-4768-9d00-188f751b7726	2024-12-10	Warnings	Exact identifier application number: M012
Adult Allergy Relief	CALMCO ALLERGY RELIEF	CalmCo	08288825-0f38-b6a3-e063-6394a90aa358	2024-12-07	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola Ag	c142663f-086e-4ab7-a758-9107d7077537	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	984c9793-163c-4b97-b244-9b471966a122	2024-12-05	Warnings	Exact identifier application number: M012
BENZEDREX	PROPYLHEXEDRINE	BF ASCHER AND CO INC	00d8c237-3eee-1d9f-e063-6394a90aeb86	2024-12-05	Warnings	Exact identifier application number: M012
Cold Multi Symptom Daytime Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	d5cbb5b0-564c-429e-b680-fa683e796393	2024-12-05	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	de8a623f-7b10-4d56-a74b-3737e7716ffe	2024-12-05	Warnings	Exact identifier application number: M012
Cold Max Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	9773958b-c5e5-4da7-a8e9-6b6c223a2b30	2024-12-05	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	399e0e51-c2a7-451c-b74d-d3db140cef69	2024-12-05	Warnings	Exact identifier application number: M012
Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	09531edc-8dbd-451f-ae02-f922e9e8c248	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	71ca8af7-172d-40da-be1e-ff3ab5568e74	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	b790a91c-33be-4bc3-bdeb-eae6f366f085	2024-12-05	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola Ag	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola Ag	8b2d5c0f-509e-447d-b071-d73c4785f120	2024-12-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
336096P2WE	RACEPINEPHRINE HYDROCHLORIDE	329-63-5	RACEPINEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310133	racepinephrine 2.25 % Inhalation Solution	PSN	3598ac5b-29f9-f002-e063-6294a90a62cb	7
310133	racepinephrine 22.5 MG/ML Inhalation Solution	SCD	3598ac5b-29f9-f002-e063-6294a90a62cb	7
310133	racepinephrine 11.25 MG per 0.5 ML Inhalation Solution	SY	3598ac5b-29f9-f002-e063-6294a90a62cb	7
310133	racepinephrine 2.25 % Inhalation Solution	SY	3598ac5b-29f9-f002-e063-6294a90a62cb	7
310133	racepinephrine 2.25 % Inhalation Solution	PSN	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2
310133	racepinephrine 22.5 MG/ML Inhalation Solution	SCD	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2
310133	racepinephrine 11.25 MG per 0.5 ML Inhalation Solution	SY	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2
310133	racepinephrine 2.25 % Inhalation Solution	SY	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73117-509-01	73117050901	1 mL in 1 BOTTLE, SPRAY (73117-509-01)	1 ml	2025-11-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NebuClear MD - Blue Echo Care LLC	Blue Echo Care LLC	2026-05-28	HUMAN OTC DRUG LABEL	7
NebuClear MD - Blue Echo Care LLC	Blue Echo Care LLC	2026-05-28	HUMAN OTC DRUG LABEL	2
Device - NebuClear MD Hand-held Rubber Bulb Nebulizer - Blue Echo Care LLC	Blue Echo Care LLC	2026-05-11	HUMAN OTC DRUG LABEL	4