SPEEDGEL RX
- Product NDC
- 35781-0210
- Requested package NDC
- 35781-0210-1
- 11-digit product format
- 357810210
- Labeler code
- 35781
- Product ID
- 35781-0210_ea4e4eac-3e35-5370-e053-2995a90a9cab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Gensco Laboratories, LLC
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2011-12-01
- Marketing end
- 0000-00-00
- Substance
- ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL
- Active strength
- 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
- Pharmacologic classes
- Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 35781-0210 | 35781-0210-1 | I | Inactivated by FDA | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51989a2b-944a-b31f-835e-469c133570ad | Product name | 2 | 20250716 |
| 11e940b0-77bd-45d4-a80f-028ff6bd67e2 | Product name | 2 | 20250214 |
| 14efe2b0-2695-4943-8b2f-24f519c99fed | Product name | 1 | 20231023 |
| bf4e8ffd-8f13-3050-5248-581676b7ea42 | Product name | 6 | 20221214 |
| 987af351-b977-4822-ac44-c76d29e24e78 | Product name | 1 | 20190611 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 35781-0210-1 | 2023-07-28 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-2 | 2023-07-28 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-9 | 2023-07-28 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-1 | 2022-10-05 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-2 | 2022-10-05 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-9 | 2022-10-05 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-1 | 2022-07-29 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-2 | 2022-07-29 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
| 35781-0210-9 | 2022-07-29 | SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35781-0210-1 | SPEEDGEL RX | 1 in 1 CARTON | GEL | 1 | 8 | |
| 35781-0210-1 | SPEEDGEL RX | 10 mL in 1 BOTTLE, DISPENSING | GEL | 10 | 8 | |
| 35781-0210-2 | SPEEDGEL RX | 1 in 1 CARTON | GEL | 1 | 8 | |
| 35781-0210-2 | SPEEDGEL RX | 30 mL in 1 BOTTLE, DISPENSING | GEL | 30 | 8 | |
| 35781-0210-9 | SPEEDGEL RX | 1 in 1 CARTON | GEL | 1 | 8 | |
| 35781-0210-9 | SPEEDGEL RX | 90 mL in 1 BOTTLE, DISPENSING | GEL | 90 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35781-0210-1 | ML - Milliliter | 35781-0210 | 11a97c98-f8ca-4730-b7ad-18e5c84f19b4 | 1 | 2013-02-13 |
| 35781-0210-2 | ML - Milliliter | 35781-0210 | cd484876-f4a4-4c51-9801-04b6418d1f33 | 1 | 2013-02-13 |
| 35781-0210-9 | ML - Milliliter | 35781-0210 | 6aab4839-0147-4103-a899-6bbf99c905f7 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35781-0210 | SPEEDGEL RX (ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE) GEL [GENSCO LABORATORIES, LLC] | 8 | Legacy NDC, 6 package rows | 20221007_abc4b132-4d35-46a4-9a8e-9bd4c7a0f4b0.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 35781-0210-1 | 35781021001 | 1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1) > 10 mL in 1 BOTTLE, DISPENSING | 2011-12-01 | 0000-00-00 | No | No | Current |