SINUS

Product NDC: 66492-004
11-digit product format: 664920004
Labeler code: 66492
Product ID: 66492-004_d44a03c4-5a56-bf16-e053-2995a90aca66
Type: HUMAN OTC DRUG
Nonproprietary name: Pulsatilla, Euphorbium, Allium Cepa, Histaminum, Luffa Operculata, Sabadilla, Hepar Sulfur.
Dosage form: LIQUID
Route: NASAL
Labeler: Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2017-09-01
Substance: CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED
Active strength: 12; 4; 6; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CALCIUM SULFIDE	12 [hp_X]/mL
EUPHORBIA RESINIFERA RESIN	4 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE	6 [hp_X]/mL
LUFFA OPERCULATA FRUIT	6 [hp_X]/mL
ONION	6 [hp_X]/mL
PULSATILLA VULGARIS	2 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED	6 [hp_X]/mL

Field, Values table
Field	Values
Unii	1MBW07J51Q, 1TI1O9028K, 3POA0Q644U, C4MO6809HU, 492225Q21H, I76KB35JEV, 6NAF1689IO

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66492-004-02	SINUS	30 mL in 1 BOTTLE, SPRAY	LIQUID	30		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66492-004	SINUS (PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR.) LIQUID [BE WELL MEDICAL DBA RICHARD CLEMENT NUTRITION Y BE WELL HOMEOPATHICS]	4	Current NDC, Legacy NDC, 1 package rows	20211230_6680b1bf-360f-4b98-ac27-9f656de6783e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1MBW07J51Q	CALCIUM SULFIDE	20548-54-3	CALCIUM SULFIDE
1TI1O9028K	EUPHORBIA RESINIFERA RESIN		EUPHORBIA RESINIFERA RESIN
3POA0Q644U	HISTAMINE DIHYDROCHLORIDE	56-92-8	HISTAMINE DIHYDROCHLORIDE
C4MO6809HU	LUFFA OPERCULATA FRUIT		LUFFA OPERCULATA FRUIT
492225Q21H	ONION		ONION
6NAF1689IO	SCHOENOCAULON OFFICINALE SEED		SCHOENOCAULON OFFICINALE SEED

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66492-004-02	66492000402	30 mL in 1 BOTTLE, SPRAY (66492-004-02)	30 ml	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SINUS NASAL SPRAY	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics	2021-12-29	HUMAN OTC DRUG LABEL	4