Baby Oral Pain Relief oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla 12 [hp_X]/g; 12 [hp_X]/g; 6 [hp_X]/g; 30 [hp_X]/g; 12 [hp_X]/g; 12 [hp_X]/g Tablet
by Hyland' Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC
NDC 54973-3315-01
🏷️ FDA NDC (as labeled)
54973-3315-1
billing pads the package segment with a zero
This package
Contains125 g in 1 bottle, plastic
Pack sizes2 compare ↓
Also comes in:
80 g 54973-3315-07
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
54973-3315-1
Product NDC
54973-3315
11-digit billing NDC
54973331501
UNII
2E32821G6I, 91D9GV0Z28, 3SW678MX72, O80TY208ZW, G0R4UBI2ZZ, 91GQH8I5F7
SPL Set ID
5904f126-e8f0-a892-e053-2991aa0aef0f
Established class (EPC)
Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity
Chemical class
Allergens; Dietary Proteins; Plant Proteins; Seed Storage Proteins
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-08-17
Route
ORAL
Dosage form
TABLET
Substance
OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; ARNICA MONTANA; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM
Why two NDCs?
The FDA registers this code as 54973-3315-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 54973-3315-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerHyland' Inc.
Labeler code54973
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
This is an unapproved homeopathic tablet taken by mouth that contains oyster shell calcium carbonate, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum, and matricaria chamomila. In homeopathic practice, these ingredients are traditionally used to address teething discomfort and related infant fussiness, though homeopathic products are marketed based on historical use and tradition rather than evaluated by the FDA for effectiveness. The product is not approved by the FDA as a drug.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
80 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Baby Oral Pain Relief 12 [hp_X]/g; 12 [hp_X]/g; 6 [hp_X]/g; 30 [hp_X]/g; 12 [hp_X]/g; 12 [hp_X]/gthis 54973-3315-01 | Hyland' | 1 bottle | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54973-3315-01 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTIC | 2017-08-17 | Active |
| 54973-3315-07 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7) / 80 g in 1 BOTTLE, PLASTIC | 2017-08-17 | Active |
Pack size FAQ
What quantity is in NDC 54973-3315-01?
NDC 54973-3315-01 is listed by the FDA — 1 bottle, plastic in 1 carton / 125 g in 1 bottle, plastic.
What NDC number is used to bill for this package of Baby Oral Pain Relief oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla 12 [hp_X]/g; 12 [hp_X]/g; 6 [hp_X]/g; 30 [hp_X]/g; 12 [hp_X]/g; 12 [hp_X]/g Tablet?
Bill NDC 54973-3315-01 — the 11-digit billing format is 54973331501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
Baby Oral Pain Relief oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla 12 [hp_X]/g; 12 [hp_X]/g; 6 [hp_X]/g; 30 [hp_X]/g; 12 [hp_X]/g; 12 [hp_X]/g TABLET is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 54973-3315-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 54973-3315-01, written without dashes as 54973331501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 54973-3315-01, the first segment (54973) is the labeler code FDA assigned to Hyland' Inc.; the middle segment (3315) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hyland' Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (54973-3315-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hyland' Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses ■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability
⏱️ Dosage and Administration ▾
Directions ■ Use as directed. Children under 6 months At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Children 6 months to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.
⚠️ Warnings ▾
Warnings Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens. Keep out of reach of children
🧪 Active Ingredient ▾
Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums "HPUS" is the Homeopathic Pharmacopoeia of the United States.
🧪 Inactive Ingredients ▾
Inactive ingredients Acacia Gum, Lactose.
🎯 Purpose ▾
Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.