Otitis Media Drops

Product NDC: 63083-2153
11-digit product format: 630832153
Labeler code: 63083
Product ID: 63083-2153_01edc603-bccd-4047-a651-145796e5cf51
Type: HUMAN OTC DRUG
Nonproprietary name: Otitis Media Drops
Dosage form: LIQUID
Route: ORAL
Labeler: Professional Complementary Health Formulas
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 1984-08-15
Substance: OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA MONTANA WHOLE; ACONITUM NAPELLUS WHOLE; SUS SCROFA EAR; AMARYLLIS BELLADONNA WHOLE; TELLURIUM; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; STREPTOCOCCUS PNEUMONIAE; HAEMOPHILUS INFLUENZAE
Active strength: 3; 4; 6; 6; 12; 12; 12; 30; 30; 30; 60 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63083-2153-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63083-2153-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63083-2153-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63083-2153-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63083-2153-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63083-2153-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63083-2153-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63083-2153-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63083-2153-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63083-2153-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63083-2153-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63083-2153-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63083-2153-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63083-2153-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63083-2153-2	`1332a3947898…`	`d4bfe170f9cd…`

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: Otitis Media Drops
Brand name suffix: 2153
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE	3 [hp_X]/59mL
PULSATILLA MONTANA WHOLE	4 [hp_X]/59mL
ACONITUM NAPELLUS WHOLE	6 [hp_X]/59mL
SUS SCROFA EAR	6 [hp_X]/59mL
AMARYLLIS BELLADONNA WHOLE	12 [hp_X]/59mL
TELLURIUM	12 [hp_X]/59mL
FERROSOFERRIC PHOSPHATE	12 [hp_X]/59mL
GELSEMIUM SEMPERVIRENS ROOT	30 [hp_X]/59mL
MERCURY	30 [hp_X]/59mL
STREPTOCOCCUS PNEUMONIAE	30 [hp_X]/59mL
HAEMOPHILUS INFLUENZAE	60 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2E32821G6I	Internal UNII lookup
24K790T39B	Internal UNII lookup
U0NQ8555JD	Internal UNII lookup
7DX2J287CV	Internal UNII lookup
11B89M58UN	Internal UNII lookup
NQA0O090ZJ	Internal UNII lookup
91GQH8I5F7	Internal UNII lookup
639KR60Q1Q	Internal UNII lookup
FXS1BY2PGL	Internal UNII lookup
BT6U234YR2	Internal UNII lookup
K738E2MB3I	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
9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2026-01-08	C153
2026-01-08	C153
2024-01-30	C153
2024-01-30	C153

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63083-2153-2	Otitis Media Drops2153	59 mL in 1 BOTTLE, DROPPER	LIQUID	59		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63083-2153	OTITIS MEDIA DROPS 2153 (OTITIS MEDIA DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]	1	Current NDC, Legacy NDC, 1 package rows	20220216_9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172.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
Otitis Media Drops 2153	OTITIS MEDIA DROPS	Professional Complementary Health Formulas	9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172	2026-01-08	Warnings	Exact identifier ndc (product): 63083-2153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2E32821G6I	OYSTER SHELL CALCIUM CARBONATE, CRUDE		OYSTER SHELL CALCIUM CARBONATE, CRUDE
7DX2J287CV	SUS SCROFA EAR		SUS SCROFA EAR
11B89M58UN	AMARYLLIS BELLADONNA WHOLE		AMARYLLIS BELLADONNA WHOLE
NQA0O090ZJ	TELLURIUM	13494-80-9	TELLURIUM
91GQH8I5F7	FERROSOFERRIC PHOSPHATE		FERROSOFERRIC PHOSPHATE
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
FXS1BY2PGL	MERCURY	7439-97-6	MERCURY
BT6U234YR2	STREPTOCOCCUS PNEUMONIAE		STREPTOCOCCUS PNEUMONIAE
K738E2MB3I	HAEMOPHILUS INFLUENZAE		HAEMOPHILUS INFLUENZAE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63083-2153-2	63083215302	59 mL in 1 BOTTLE, DROPPER (63083-2153-2)	59 ml	1985-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
C153	Professional Complementary Health Formulas \| Natural Pharmaceutical Manufacturing LLC	2026-01-08	HUMAN OTC DRUG LABEL	2