Muscle Ice

Product NDC: 57520-0628
Requested package NDC: 57520-0628-1
11-digit product format: 575200628
Labeler code: 57520
Product ID: 57520-0628_7027b3ce-a6c9-43c3-b0d4-16d32f77f49a
Type: HUMAN OTC DRUG
Nonproprietary name: Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea,
Dosage form: GEL
Route: TOPICAL
Labeler: Apotheca Company
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2011-10-24
Marketing end: 2023-04-12
Substance: BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE
Active strength: 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	57520-0628	57520-0628-1	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-0628-1	2022-04-29	C162847	48780-1	9d75b9d0-e0d7-f424-e053-dadaa90a57ce	Muscle Ice
57520-0628-1	2020-01-31	C162847	48780-1	9d75b9d0-e0d7-f424-e053-dadaa90a57ce	Muscle Ice

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BELLIS PERENNIS	ACTIVE INGREDIENT	2HU33I03UY	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
COMFREY ROOT	ACTIVE INGREDIENT	M9VVZ08EKQ	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
LEDUM PALUSTRE TWIG	ACTIVE INGREDIENT	877L01IZ0P	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	ACTIVE INGREDIENT	HF539G9L3Q	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE INGREDIENT	N94C2U587S	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
BELLIS PERENNIS	ACTIVE MOIETY	2HU33I03UY	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
COMFREY ROOT	ACTIVE MOIETY	M9VVZ08EKQ	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
LEDUM PALUSTRE TWIG	ACTIVE MOIETY	877L01IZ0P	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE MOIETY	N94C2U587S	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
SILICON	ACTIVE MOIETY	Z4152N8IUI	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
CAMPHOR OIL	INACTIVE INGREDIENT	75IZZ8Y727	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)	INACTIVE INGREDIENT	59TL3WG5CO	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
GINGER OIL	INACTIVE INGREDIENT	SAS9Z1SVUK	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
HYPERICUM OIL	INACTIVE INGREDIENT	OZU2FC70HY	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
POLYETHYLENE GLYCOL 700	INACTIVE INGREDIENT	762678AC5R	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2HU33I03UY	BELLIS PERENNIS		BELLIS PERENNIS
M9VVZ08EKQ	COMFREY ROOT		COMFREY ROOT
HF539G9L3Q	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	7782-75-4	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
N94C2U587S	RUTA GRAVEOLENS FLOWERING TOP		RUTA GRAVEOLENS FLOWERING TOP
ETJ7Z6XBU4	SILICON DIOXIDE	7631-86-9	SILICON DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57520-0628-1	57520062801	105 g in 1 TUBE (57520-0628-1)	105 g	2011-10-24	2023-04-12	No	No	Current