Otoflam

Product NDC: 44911-0513
Requested package NDC: 44911-0513-1
11-digit product format: 449110513
Labeler code: 44911
Product ID: 44911-0513_b1b1bae2-148d-43f0-a7fe-f35c19a1bd31
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Pratensis), Silicea, Chamomilla.
Dosage form: LIQUID
Route: ORAL
Labeler: Energique, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2019-10-03
Substance: ATROPA BELLADONNA WHOLE; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; MATRICARIA CHAMOMILLA WHOLE
Active strength: 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
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 · 5 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…`

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: Otoflam
Brand name suffix: HP
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATROPA BELLADONNA WHOLE	30 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP	30 [hp_X]/mL
SOLANUM DULCAMARA TOP	30 [hp_X]/mL
FERROSOFERRIC PHOSPHATE	30 [hp_X]/mL
CALCIUM SULFIDE	30 [hp_X]/mL
POTASSIUM DICHROMATE	30 [hp_X]/mL
MERCURIUS SOLUBILIS	30 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE	30 [hp_X]/mL
SILICON DIOXIDE	30 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE	30 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DSV74G1P2J	Internal UNII lookup
Q28R5GF371	Internal UNII lookup
KPS1B1162N	Internal UNII lookup
91GQH8I5F7	Internal UNII lookup
1MBW07J51Q	Internal UNII lookup
T4423S18FM	Internal UNII lookup
324Y4038G2	Internal UNII lookup
8E272251DI	Internal UNII lookup
ETJ7Z6XBU4	Internal UNII lookup
G0R4UBI2ZZ	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
76c6b494-43d1-4508-bea4-4f9026b4a5fa	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-10-29	DRUG FACTS:
2023-01-30	DRUG FACTS:
2021-09-01	DRUG FACTS:
2021-01-29	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44911-0513-1	OtoflamHP	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44911-0513	OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.) LIQUID [ENERGIQUE, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241031_76c6b494-43d1-4508-bea4-4f9026b4a5fa.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
Otoflam HP	BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.	Energique, Inc.	76c6b494-43d1-4508-bea4-4f9026b4a5fa	2024-10-29	Warnings	Exact identifier ndc (package): 44911-0513-1 ndc (product): 44911-0513 ndc11 (package): 44911051301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q28R5GF371	CONIUM MACULATUM FLOWERING TOP		CONIUM MACULATUM FLOWERING TOP
KPS1B1162N	SOLANUM DULCAMARA TOP		SOLANUM DULCAMARA TOP
91GQH8I5F7	FERROSOFERRIC PHOSPHATE		FERROSOFERRIC PHOSPHATE
1MBW07J51Q	CALCIUM SULFIDE	20548-54-3	CALCIUM SULFIDE
T4423S18FM	POTASSIUM DICHROMATE	7778-50-9	POTASSIUM DICHROMATE
324Y4038G2	MERCURIUS SOLUBILIS		MERCURIUS SOLUBILIS
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
44911-0513-1	44911051301	30 mL in 1 BOTTLE, DROPPER (44911-0513-1)	30 ml	2019-10-03	0000-00-00	No	No	Current