Back, Neck and Sciatic Rescue

Product NDC: 43846-0076
11-digit product format: 438460076
Labeler code: 43846
Product ID: 43846-0076_2c65e327-2421-4740-b4d5-737e60c903ac
Type: HUMAN OTC DRUG
Nonproprietary name: Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum
Dosage form: GEL
Route: TOPICAL
Labeler: Peaceful Mountain, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2021-03-17
Marketing end: 2030-01-09
Substance: CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM WHOLE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG
Active strength: 6; 30; 6; 6; 3; 4; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X]/g
CONIUM MACULATUM FLOWERING TOP	30 [hp_X]/g
GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]/g
GUAIACUM OFFICINALE RESIN	6 [hp_X]/g
HYPERICUM PERFORATUM WHOLE	3 [hp_X]/g
PHYTOLACCA AMERICANA ROOT	4 [hp_X]/g
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE	3 [hp_X]/g
RHODODENDRON TOMENTOSUM LEAFY TWIG	6 [hp_X]/g

Field, Values table
Field	Values
Unii	23H32AOH17, Q28R5GF371, 639KR60Q1Q, N0K2Z502R6, XK4IUX8MNB, 11E6VI8VEG, 36XQ854NWW, 877L01IZ0P

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43846-0076-1	2024-06-12	C162847	48780-1	f386c649-ab9e-0266-e053-dadaa90a7c1a	DRUG FACTS:
43846-0076-1	2023-01-30	C162847	48780-1	f386c649-ab9e-0266-e053-dadaa90a7c1a	DRUG FACTS:

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43846-0076-1	Back, Neck and Sciatic Rescue	57 g in 1 TUBE	GEL	57		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43846-0076	BACK, NECK AND SCIATIC RESCUE (PHYTOLACCA DECANDRA, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, COLOCYNTHIS, GELSEMIUM SEMPERVIRENS, GUAIACUM, LEDUM PALUSTRE, CONIUM MACULATUM) GEL [PEACEFUL MOUNTAIN, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250316_dc2033a7-a322-4733-8bfe-5a36fe1fa807.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
23H32AOH17	CITRULLUS COLOCYNTHIS FRUIT PULP		CITRULLUS COLOCYNTHIS FRUIT PULP
Q28R5GF371	CONIUM MACULATUM FLOWERING TOP		CONIUM MACULATUM FLOWERING TOP
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
N0K2Z502R6	GUAIACUM OFFICINALE RESIN	9000-29-7	GUAIACUM OFFICINALE RESIN
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
877L01IZ0P	RHODODENDRON TOMENTOSUM LEAFY TWIG		RHODODENDRON TOMENTOSUM LEAFY TWIG

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43846-0076-1	43846007601	57 g in 1 TUBE (43846-0076-1)	57 g	2021-03-17	2030-01-09	No	No	Current