SINECCHi
- Manufacturer
- Hahnemann Laboratories Inc. dba Alpine Pharmaceuticals | Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
- Effective date
- 2025-01-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:30:16
Label at a glance#
ProductSINECCHi
Active ingredientARNICA MONTANA
Label structure1 sections
Label contents#
Full prescribing information#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63545-516-01 | 2023-09-19 | C162847 | 48780-1 | 9d75b9d0-2185-f424-e053-dadaa90a57ce | 36ffb596-1c53-49e6-9228-5c2d378e1163 |
| 63545-516-01 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-2185-f424-e053-dadaa90a57ce | 36ffb596-1c53-49e6-9228-5c2d378e1163 |
| 63545-516-01 | 2020-02-24 | C162847 | 48780-1 | 9d75b9d0-2185-f424-e053-dadaa90a57ce | 36ffb596-1c53-49e6-9228-5c2d378e1163 |
| 63545-516-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2185-f424-e053-dadaa90a57ce | 36ffb596-1c53-49e6-9228-5c2d378e1163 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63545-516-01 | SINECCHi | 4 in 1 BLISTER PACK | CAPSULE | 4 | 5 | |
| 63545-516-02 | SINECCHi | 1 in 1 BOX | CAPSULE | 1 | 5 | |
| 63545-516-03 | SINECCHi | 12 in 1 BOX | CAPSULE | 12 | 5 | |
| 63545-516-04 | SINECCHi | 36 in 1 BOX | CAPSULE | 36 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 2 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Products#
Every source-derived product name is available through these pages.
- SINECCHi
- Arnica montana
- SUCROSE
- TITANIUM DIOXIDE
- HYPROMELLOSES
- FERRIC OXIDE RED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63545-516 | 63545-516-01, 63545-516-02, 63545-516-03, 63545-516-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SINECCHi | ARNICA MONTANA | Hahnemann Laboratories Inc. dba Alpine Pharmaceuticals | 36ffb596-1c53-49e6-9228-5c2d378e1163 | 2025-01-09 | 63545-516-01 63545-516-02 63545-516-03 63545-516-04 63545-516 63545051603 63545051601 63545051602 63545051604 2b491719-149a-ce7d-e063-6294a90ae655 36ffb596-1c53-49e6-9228-5c2d378e1163 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
