Earache

Product NDC: 59779-568
Requested package NDC: 59779-568-15
11-digit product format: 597790568
Labeler code: 59779
Product ID: 59779-568_2f5779bc-e11c-4ac1-b793-63e5f4c25d5f
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Calcarea Carbonica, Chamomilla, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sulphur
Dosage form: LIQUID
Route: AURICULAR (OTIC)
Labeler: CVS Pharmacy
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2016-04-22
Marketing end: 0000-00-00
Substance: ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR
Active strength: 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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	59779-568	59779-568-15	I	Inactivated by FDA		2026-10-16

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, 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
59779-568-15	2022-01-28	C162847	48780-1	9d75b9d0-33fa-f424-e053-dadaa90a57ce	Drug Facts:
59779-568-15	2020-04-20	C162847	48780-1	9d75b9d0-33fa-f424-e053-dadaa90a57ce	Drug Facts:
59779-568-15	2020-01-31	C162847	48780-1	9d75b9d0-33fa-f424-e053-dadaa90a57ce	Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-568-15	Earache	10 mL in 1 BOTTLE, DROPPER	LIQUID	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-568	EARACHE (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR) LIQUID [CVS PHARMACY]	4	Legacy NDC, 1 package rows	20200430_e9767a0e-3456-4805-9169-35852cfe5bb3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
2E32821G6I	OYSTER SHELL CALCIUM CARBONATE, CRUDE		OYSTER SHELL CALCIUM CARBONATE, CRUDE
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
70FD1KFU70	SULFUR	7704-34-9	SULFUR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-568-15	59779056815	10 mL in 1 BOTTLE, DROPPER (59779-568-15)	10 ml	2016-04-22	0000-00-00	No	No	Current