Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Sambucol Cold and Flu Relief NDC 52053-0004
bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum · Bryonia alba root 6 [hp_X]/mg + 4 more ingredients · Tablet · Oral · PharmaCare US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52053-0004-1 | 5205300040152053000401 | 4 BLISTER PACK in 1 CARTON (52053-0004-1) / 4500 mg in 1 BLISTER PACK (52053-0004-2)Marketed from Oct 4, 2021 |
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)
- Sambucol Cold and Flu Relief
- Generic name (nonproprietary)
- bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum
- Active ingredients
- Bryonia alba root — 6 [hp_X]/mgGelsemium sempervirens root — 6 [hp_X]/mgSambucus nigra flowering top — 3 [hp_X]/mgSulfur — 12 [hp_X]/mgZinc gluconate — 2 [hp_X]/mg
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PharmaCare US, Inc.NDC labeler code 52053
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 52053-0004_fc0aa1b5-3fea-406c-b8e3-151531f1c0b8SPL ID fc0aa1b5-3fea-406c-b8e3-151531f1c0b8SPL set ID 7dace656-ee97-4931-869f-8c8022757abbUNII T7J046YI2B, 639KR60Q1Q, CT03BSA18U, 70FD1KFU70, U6WSN5SQ1Z
- Pharmacologic class
- Copper Absorption Inhibitor
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
N452053000401followed by a unit qualifier and the quantityPackage 52053-0004-01. 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: • Temporarily relieves cold & flu symptoms.** • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.** • Also temporarily relieves body aches associated with the flu.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Excerpt only. Read the full label for complete information.
About NDC 52053-0004
- What is NDC 52053-0004?
- 52053-0004 is the product NDC for Sambucol Cold and Flu Relief, Bryonia alba root 6 [hp_X]/mg + 4 more ingredients tablet, listed with the FDA by PharmaCare US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sambucol Cold and Flu Relief (Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum).
- What is the active ingredient?
- Bryonia alba root, Gelsemium sempervirens root, Sambucus nigra flowering top, Sulfur, Zinc gluconate.
- Who is the labeler?
- PharmaCare US, Inc., NDC labeler code 52053. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sambucol Cold and Flu Relief?
- 1 other product NDC are listed under this name. See all Sambucol Cold and Flu Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sambucol Cold and Flu Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sambucol Cold and Flu Reliefbryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum | Bryonia alba root 6 [hp_X]/mg + 4 more ingredients | Tablet, Orally disintegratingOral | PharmaCare US, Inc. | 52053-0001 | 52053-0001-02 |