Osteotone

Product NDC: 44911-0322
Requested package NDC: 44911-0322-1
11-digit product format: 449110322
Labeler code: 44911
Product ID: 44911-0322_ad6bb96c-e218-4691-ad1d-fbcddda288bc
Type: HUMAN OTC DRUG
Nonproprietary name: Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Causticum, Hekla Lava, Rhus Tox, Silicea
Dosage form: LIQUID
Route: ORAL
Labeler: Energique, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2016-02-01
Marketing end: 2021-02-23
Substance: COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE
Active strength: 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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	44911-0322	44911-0322-1	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M9VVZ08EKQ	COMFREY ROOT		COMFREY ROOT
2E32821G6I	OYSTER SHELL CALCIUM CARBONATE, CRUDE		OYSTER SHELL CALCIUM CARBONATE, CRUDE
O3B55K4YKI	CALCIUM FLUORIDE	7789-75-5	CALCIUM FLUORIDE
91D9GV0Z28	TRIBASIC CALCIUM PHOSPHATE	1306-06-5	TRIBASIC CALCIUM PHOSPHATE
DD5FO1WKFU	CAUSTICUM		CAUSTICUM
C21158IIRK	HEKLA LAVA		HEKLA LAVA
6IO182RP7A	TOXICODENDRON PUBESCENS LEAF		TOXICODENDRON PUBESCENS LEAF
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
44911-0322-1	44911032201	30 mL in 1 BOTTLE, DROPPER (44911-0322-1)	30 ml	2016-02-01	2021-02-23	No	No	Current

Osteotone

NDC auxiliary status#

Observed NDC auxiliary status history#

Related Records#

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Packages#

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