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
- ACONITUM NAPELLUS WHOLE; AMARYLLIS BELLADONNA WHOLE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HAEMOPHILUS INFLUENZAE; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA MONTANA WHOLE; STREPTOCOCCUS PNEUMONIAE; SUS SCROFA EAR; TELLURIUM
- Active strength
- 6; 12; 12; 30; 60; 30; 3; 4; 30; 6; 12 [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
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 |
|---|
| ACONITUM NAPELLUS WHOLE | 6 [hp_X]/59mL |
| AMARYLLIS BELLADONNA WHOLE | 12 [hp_X]/59mL |
| FERROSOFERRIC PHOSPHATE | 12 [hp_X]/59mL |
| GELSEMIUM SEMPERVIRENS ROOT | 30 [hp_X]/59mL |
| HAEMOPHILUS INFLUENZAE | 60 [hp_X]/59mL |
| MERCURY | 30 [hp_X]/59mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 3 [hp_X]/59mL |
| PULSATILLA MONTANA WHOLE | 4 [hp_X]/59mL |
| STREPTOCOCCUS PNEUMONIAE | 30 [hp_X]/59mL |
| SUS SCROFA EAR | 6 [hp_X]/59mL |
| TELLURIUM | 12 [hp_X]/59mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U0NQ8555JD, 11B89M58UN, 91GQH8I5F7, 639KR60Q1Q, K738E2MB3I, FXS1BY2PGL, 2E32821G6I, 24K790T39B, BT6U234YR2, 7DX2J287CV, NQA0O090ZJ |
FDA-Initiated Inactive NDC Indexing#
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 |
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 |