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Headache Relief Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, 100-count — NDC 54973-4008-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Headache Relief Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, 100-count — NDC 54973-4008-1 (Billing 54973-4008-01)

by Hyland's Inc. · 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Headache Relief Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet from Hyland's Inc., marketed since Apr 2020 and currently FDA-listed. It is this product's only package size.

NDC 54973-4008-01
🏷️ FDA NDC (as labeled) 54973-4008-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 54973-4008-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54973 labeler · 4008 product · 1 package
Package marketed since
Apr 3, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5497340081 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54973-4008-1
Product NDC 54973-4008
11-digit billing NDC 54973400801
UNII 639KR60Q1Q, 62I3C8233L, WQZ3G9PF0H, X43D4L3DQC
SPL Set ID a58f376e-90ed-d5f5-e053-2a95a90a0442
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-03
Route ORAL
Dosage form TABLET
Substance GELSEMIUM SEMPERVIRENS ROOT; IPECAC; ATROPA BELLADONNA; IRIS VERSICOLOR ROOT
Why two NDCs? The FDA registers this code as 54973-4008-1 — 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 → 54973-4008-01. 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.

Clinical

🧪 What is this product?

This is a homeopathic tablet taken by mouth containing atropa belladonna, gelsemium sempervirens root, ipecac, and iris versicolor root. In homeopathic practice, these plant-derived substances are traditionally used to address symptoms associated with headaches. Homeopathic products are based on traditional use rather than clinical evidence and have not been evaluated by the FDA for safety or effectiveness.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 systemPer eachPer 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54973-4008-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE 2020-04-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Headache Relief 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]this 54973-4008-01 Hyland's 100 tablets — — 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

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color white
ShapeRound
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAcacia Gum, Lactose.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerHyland's Inc.
Labeler code54973
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio69 products on file

More NDCs from Hyland's Inc. labeler code 54973

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.

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Uses ■ Temporarily relieves headaches

⏱️ Dosage and Administration 33 words ▾

Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved. Children under 12 years Consult a physician.

⚠️ Warnings 87 words ▾

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ new symptoms occur.

Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

🆘 Overdosage 38 words ▾

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

🧪 Active Ingredient 42 words ▾

Active ingredients Active ingredients Purpose Belladonna 12X HPUS (0.0000000000003% Alkaloids, calculated) headache Gelsemium Sempervirens 6X HPUS headache Ipecacuanha 6X HPUS headache Iris Versicolor 6X HPUS headache "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients Acacia Gum, Lactose.

🎯 Purpose 2 words ▾

Headache Relief

📄 Do Not Use 6 words ▾

Do not use more than directed.

📄 Ask a Doctor Before Use If 18 words ▾

Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ new symptoms occur.

🤰 If Pregnant or Breast-Feeding 13 words ▾

As with any drug, ask a doctor before use if pregnant or breast-feeding.

📄 Keep Out of Reach of Children 11 words ▾

Keep this and all medications out of the reach of children.

📄 Other Information 20 words ▾

Other information ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 624-9659

📄 Package Label / Principal Display Panel 41 words ▾

Principal Display Panel HOMEOPATHIC NDC 54973-4008-1 SINCE 1903 Hyland's Headache Relief * TOUGH ON PAIN - GENTLE ON YOU NO ACETAMINOPHEN NO IBUPROFEN NO KNOWN DRUG INTERACTIONS 100 QUICK-DISSOLVING TABLETS NATURAL RELIEF *SEE NOTE ON BACK PANEL BELOW DRUG FACTS carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Headache Relief Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 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 ✓ Available
Inactive ingredients (structured) ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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's Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hyland's 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.
← 54973-3431-01 · Hyland's 54973-4009-01 · Hyland's →
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.