Earache Relief

Product NDC: 43689-0020
Requested package NDC: 43689-0020-2
11-digit product format: 436890020
Labeler code: 43689
Product ID: 43689-0020_32934d7c-c3dc-4bfc-8b8c-ffbbc39768de
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (Vulgaris)
Dosage form: TABLET
Route: ORAL
Labeler: The Magni Company
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2016-05-09
Substance: ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA WHOLE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PLANTAGO MAJOR WHOLE; PULSATILLA VULGARIS WHOLE
Active strength: 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
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…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Earache Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATROPA BELLADONNA	12 [hp_X]/1
OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE	12 [hp_X]/1
CALCIUM SULFIDE	12 [hp_X]/1
POTASSIUM DICHROMATE	12 [hp_X]/1
LYCOPODIUM CLAVATUM SPORE	12 [hp_X]/1
PLANTAGO MAJOR WHOLE	12 [hp_X]/1
PULSATILLA VULGARIS WHOLE	12 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WQZ3G9PF0H	Internal UNII lookup
2E32821G6I	Internal UNII lookup
G0R4UBI2ZZ	Internal UNII lookup
1MBW07J51Q	Internal UNII lookup
T4423S18FM	Internal UNII lookup
C88X29Y479	Internal UNII lookup
W2469WNO6U	Internal UNII lookup
I76KB35JEV	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f62001a-27b5-43cb-8006-110943facf87	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-11-05	Drug Facts:
2024-01-30	Drug Facts:
2022-01-10	Drug Facts:
2021-01-29	Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43689-0020-1	Earache Relief	90 in 1 BOTTLE	TABLET	90		4
43689-0020-2	Earache Relief	1 in 1 PACKAGE	TABLET	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43689-0020	EARACHE RELIEF (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)) TABLET [THE MAGNI COMPANY]	4	Current NDC, Legacy NDC, 2 package rows	20241107_3f62001a-27b5-43cb-8006-110943facf87.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Earache Relief	BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)	The Magni Company	3f62001a-27b5-43cb-8006-110943facf87	2024-11-05	Warnings	Exact identifier ndc (package): 43689-0020-2 ndc (product): 43689-0020 ndc11 (package): 43689002002

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
1MBW07J51Q	CALCIUM SULFIDE	20548-54-3	CALCIUM SULFIDE
T4423S18FM	POTASSIUM DICHROMATE	7778-50-9	POTASSIUM DICHROMATE
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43689-0020-2	43689002002	1 BOTTLE in 1 PACKAGE (43689-0020-2) / 90 TABLET in 1 BOTTLE (43689-0020-1)	1 bottle	2016-08-24	0000-00-00	No	No	Current