Baby Oral Pain Relief
- Product NDC
- 54973-3315
- Requested package NDC
- 54973-3315-1
- 11-digit product format
- 549733315
- Labeler code
- 54973
- Product ID
- 54973-3315_5de45f56-69ab-beeb-e063-6294a90ae76e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hyland' Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2017-08-17
- Substance
- OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; ARNICA MONTANA; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM
- Active strength
- 12; 12; 6; 30; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Baby Oral Pain Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 12 [hp_X]/g |
| TRIBASIC CALCIUM PHOSPHATE | 12 [hp_X]/g |
| ARABICA COFFEE BEAN | 6 [hp_X]/g |
| ARNICA MONTANA | 30 [hp_X]/g |
| MATRICARIA CHAMOMILLA | 12 [hp_X]/g |
| FERRUM PHOSPHORICUM | 12 [hp_X]/g |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54973-3315-1 | Baby Oral Pain Relief | 1 in 1 CARTON | TABLET | 1 | | 15 |
| 54973-3315-1 | Baby Oral Pain Relief | 125 g in 1 BOTTLE, PLASTIC | TABLET | 125 | | 15 |
| 54973-3315-3 | Baby Oral Pain Relief | 6 g in 1 PACKET | TABLET | 6 | | 15 |
| 54973-3315-7 | Baby Oral Pain Relief | 1 in 1 CARTON | TABLET | 1 | | 15 |
| 54973-3315-7 | Baby Oral Pain Relief | 80 g in 1 BOTTLE, PLASTIC | TABLET | 80 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54973-3315 | BABY ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND' INC.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20250209_5904f126-e8f0-a892-e053-2991aa0aef0f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54973-3315-1 | 54973331501 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC | 2017-08-17 | 0000-00-00 | No | No | Current |