Sinus Remedy

Product NDC: 80046-001
Requested package NDC: 80046-001-02
11-digit product format: 800460001
Labeler code: 80046
Product ID: 80046-001_16a48855-d158-489f-843f-1fe9bb9eb506
Type: HUMAN OTC DRUG
Nonproprietary name: Calc carb, Euphorbium, Hydrastis, Kali bic, Kali iod, Lycopodium, Phosphorus, Pulsatilla, Sanguinaria, Thuja occ
Dosage form: LIQUID
Route: ORAL
Labeler: Sunset 20 LLC
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2021-03-09
Marketing end: 0000-00-00
Substance: OYSTER SHELL CALCIUM CARBONATE, CRUDE; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SANGUINARIA CANADENSIS ROOT; THUJA OCCIDENTALIS LEAFY TWIG
Active strength: 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80046-001	80046-001-02	I	Inactivated by FDA		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80046-001-02	Sinus Remedy	30 mL in 1 BOTTLE	LIQUID	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80046-001	SINUS REMEDY (CALC CARB, EUPHORBIUM, HYDRASTIS, KALI BIC, KALI IOD, LYCOPODIUM, PHOSPHORUS, PULSATILLA, SANGUINARIA, THUJA OCC) LIQUID [SUNSET 20 LLC]	1	Legacy NDC, 1 package rows	20210311_f6c1d93a-b24e-48f7-98d4-a1a64909d77e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2E32821G6I	OYSTER SHELL CALCIUM CARBONATE, CRUDE		OYSTER SHELL CALCIUM CARBONATE, CRUDE
1TI1O9028K	EUPHORBIA RESINIFERA RESIN		EUPHORBIA RESINIFERA RESIN
ZW3Z11D0JV	GOLDENSEAL		GOLDENSEAL
T4423S18FM	POTASSIUM DICHROMATE	7778-50-9	POTASSIUM DICHROMATE
1C4QK22F9J	POTASSIUM IODIDE	7681-11-0	POTASSIUM IODIDE
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
N9288CD508	SANGUINARIA CANADENSIS ROOT		SANGUINARIA CANADENSIS ROOT
1NT28V9397	THUJA OCCIDENTALIS LEAFY TWIG		THUJA OCCIDENTALIS LEAFY TWIG

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80046-001-02	80046000102	30 mL in 1 BOTTLE (80046-001-02)	30 ml	2021-03-09	0000-00-00	No	No	Current