robafen
- Product NDC
- 0904-6763
- 11-digit product format
- 009046763
- Labeler code
- 0904
- Product ID
- 0904-6763_2c946d4b-760f-49e7-a3ec-367b24fbeb22
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2018-08-13
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN
- Active strength
- 200 mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 product | product | 0904-6763 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 0904-6763 | 0904-6763-16 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 0904-6763 | 0904-6763-20 | D | Discontinued by firm | 2026-10-12 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-6763-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-6763-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-6763-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-6763-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0904-6763-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0904-6763-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0904-6763-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0904-6763-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0904-6763-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0904-6763-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0904-6763-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0904-6763-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0904-6763-16 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0904-6763-16 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0904-6763-16 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0904-6763-16 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0904-6763-16 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0904-6763-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6763-16 | ML - Milliliter | 0904-6763 | ffd1de6e-9420-4f95-aeae-ee1de667f2d9 | 1 | 2019-04-11 |
| 0904-6763-20 | ML - Milliliter | 0904-6763 | 88428996-a6a1-479f-9fbd-5d5597d60697 | 1 | 2018-12-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 213155 | Robafen 200 MG in 10 mL Oral Solution | PSN | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 213155 | guaifenesin 20 MG/ML Oral Solution [Robafen] | SBD | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 213155 | Robafen 100 MG per 5 mL Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
| 213155 | Robafen 200 MG per 10 mL Oral Solution | SY | 65188fb6-1c0b-4e81-b0f7-af28d2b27b87 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6763-16 | 00904676316 | 473 mL in 1 BOTTLE (0904-6763-16) | 473 ml | 2018-12-10 | 2022-02-28 | No | No | Current |
| 0904-6763-20 | 00904676320 | 1 BOTTLE in 1 CARTON (0904-6763-20) > 118 mL in 1 BOTTLE | 1 bottle | 2018-08-13 | 0000-00-00 | No | No | Current |