Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Baby Nighttime Oral Pain Relief NDC 54973-3324
Oyster shell calcium carbonate, Crude 12 [hp_X]/g + 7 more ingredients · Tablet · Oral · Hyland' Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54973-3324-1 | 5497333240154973332401 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1) / 1 g in 1 BOTTLE, PLASTICMarketed from Aug 17, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Baby Nighttime Oral Pain Relief
- Generic name (nonproprietary)
- arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude
- Active ingredients
- Oyster shell calcium carbonate, Crude — 12 [hp_X]/gTribasic calcium phosphate — 12 [hp_X]/gMatricaria chamomilla — 12 [hp_X]/gSilicon dioxide — 12 [hp_X]/gArnica montana — 30 [hp_X]/gFerrosoferric phosphate — 12 [hp_X]/gArabica coffee bean — 6 [hp_X]/gMagnesium phosphate, Dibasic trihydrate — 12 [hp_X]/g
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Hyland' Inc.NDC labeler code 54973
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99eSPL ID 308ccf50-c319-2cd0-e063-6394a90aa99eSPL set ID 58ef86b7-5b38-1591-e053-2991aa0aa53eUNII 2E32821G6I, 91D9GV0Z28, G0R4UBI2ZZ, ETJ7Z6XBU4, O80TY208ZW, 91GQH8I5F7, 3SW678MX72, HF539G9L3Q
- Pharmacologic class
- Calculi Dissolution Agent; Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract; Osmotic Laxative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454973332401followed by a unit qualifier and the quantityPackage 54973-3324-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses ■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability ■ occasional sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 54973-3324
- What is NDC 54973-3324?
- 54973-3324 is the product NDC for Baby Nighttime Oral Pain Relief, Oyster shell calcium carbonate, Crude 12 [hp_X]/g + 7 more ingredients tablet, listed with the FDA by Hyland' Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Baby Nighttime Oral Pain Relief (Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude).
- What is the active ingredient?
- Oyster shell calcium carbonate, Crude, Tribasic calcium phosphate, Matricaria chamomilla, Silicon dioxide, Arnica montana, Ferrosoferric phosphate, Arabica coffee bean, Magnesium phosphate, Dibasic trihydrate.
- Who is the labeler?
- Hyland' Inc., NDC labeler code 54973. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Baby Nighttime Oral Pain Relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.