Neck Back Sciatic Remedy

Product NDC: 68703-215
Requested package NDC: 68703-215-04
11-digit product format: 687030215
Labeler code: 68703
Product ID: 68703-215_67da6c80-a80b-0b7d-e053-2991aa0a8f38
Type: HUMAN OTC DRUG
Nonproprietary name: Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum
Dosage form: LOTION
Route: TOPICAL
Labeler: Silver Star Brands
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2017-12-11
Marketing end: 0000-00-00
Substance: PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CITRULLUS COLOCYNTHIS FRUIT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG
Active strength: 1 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	68703-215	68703-215-04	I	Inactivated by FDA		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68703-215-04	Neck Back Sciatic Remedy	113 g in 1 JAR	LOTION	113		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68703-215	NECK BACK SCIATIC REMEDY (PHYTOLACCA DECANDRA, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, COLOCYNTHIS, GELSEMIUM SEMPERVIRENS, GUAIACUM, LEDUM PALUSTRE, CONIUM MACULATUM) LOTION [SILVER STAR BRANDS]	3	Legacy NDC, 1 package rows	20230307_5e94e5f1-52b1-e564-e053-2a91aa0a29e8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
36XQ854NWW	PSEUDOGNAPHALIUM OBTUSIFOLIUM		PSEUDOGNAPHALIUM OBTUSIFOLIUM
XK4IUX8MNB	HYPERICUM PERFORATUM		HYPERICUM PERFORATUM
Q28R5GF371	CONIUM MACULATUM FLOWERING TOP		CONIUM MACULATUM FLOWERING TOP
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
0E49E3V9U6	CITRULLUS COLOCYNTHIS FRUIT		CITRULLUS COLOCYNTHIS FRUIT
N0K2Z502R6	GUAIACUM OFFICINALE RESIN	9000-29-7	GUAIACUM OFFICINALE RESIN

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68703-215-04	68703021504	113 g in 1 JAR (68703-215-04)	113 g	2017-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Healthful™ Neck, Back & Sciatic Remedy	Silver Star Brands \| Apotheca Company	2023-03-04	HUMAN OTC DRUG LABEL	3