Tusnel Diabetic
- Product NDC
- 54859-505
- 11-digit product format
- 548590505
- Labeler code
- 54859
- Product ID
- 54859-505_471f18f8-553e-41f9-e063-6394a90ae51e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan, Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2003-12-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 54859-505-16 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 54859-505-04 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 54859-505-16 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 54859-505-04 | 9bebd1f3094a… | 5416666fcb17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tusnel Diabetic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 996520 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 66b3c094-809e-4d2c-bc15-46563de685cb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 54859-505-04 | 2020-12-23 | Llorens-TusnelDiabetic 505 |
| 54859-505-16 | 2020-12-23 | Llorens-TusnelDiabetic 505 |
| 54859-505-04 | 2020-01-31 | Llorens-TusnelDiabetic 505 |
| 54859-505-16 | 2020-01-31 | Llorens-TusnelDiabetic 505 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-505-04 | Tusnel Diabetic | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 | |
| 54859-505-16 | Tusnel Diabetic | 472 mL in 1 BOTTLE | LIQUID | 472 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-505-04 | ML - Milliliter | 54859-505 | c457a812-04f0-43fe-989e-74cbee67594f | 1 | 2012-07-24 |
| 54859-505-16 | ML - Milliliter | 54859-505 | 91be4c5f-d3cd-45dd-968d-a2ba0d8922c7 | 1 | 2020-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Walgreens NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREEN COMPANY | 5bf72e2f-15c8-466a-9e13-50654233da91 | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | 9862f84d-1c18-4ef7-86dc-98572599d417 | 2026-01-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 37853689-c9ca-4bc7-9c5b-4a68b8d778be | 2026-01-19 | Warnings | M012 |
| VAPORX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | AKRON PHARMA INC | 51b32162-0c5a-4b5b-999a-34337d816603 | 2026-01-19 | Warnings | M012 |
| Equate | OXYMETAZOLINE HCL | Walmart Inc | 2f762c24-2442-506a-e063-6394a90a3b96 | 2026-01-19 | Warnings | M012 |
| Dimetane | DIPHENHYDRAMINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 2026-01-19 | Warnings | M012 |
| nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | f681d986-9838-42d8-8ed9-732a39fbf870 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | H E B | 22d241c5-a3fd-4619-8147-91d7a4c8cf98 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Better Living Brands, LLC | 9fe63ca6-3863-4175-9aec-ecd6ebbdb249 | 2026-01-19 | Warnings | M012 |
| Good Neighbor Pharmacy Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 5749ce9d-e182-478f-ab88-b520a35a99a7 | 2026-01-19 | Warnings | M012 |
| Foster and Thrive Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 1d9150b1-2f6c-4c33-8c93-3ed1d88585e2 | 2026-01-18 | Warnings | M012 |
| HealthWise Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | ce3ceffd-3ff5-3795-e053-2995a90a827f | 2026-01-18 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 31210a95-f9dc-49db-aab5-25c4dca49266 | 2026-01-17 | Warnings | M012 |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f77226c0-b6d5-9fd0-e053-6294a90a4b57 | 2026-01-16 | Warnings | M012 |
| Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f691734b-5cf4-6eb8-e053-2a95a90aee80 | 2026-01-16 | Warnings | M012 |
| Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f771aa19-295a-9f4e-e053-6294a90a1674 | 2026-01-16 | Warnings | M012 |
| CVS Cherry Cough Drops | MENTHOL | CVS Pharmacy | de5c4b94-0420-5d43-e053-2995a90aa5a5 | 2026-01-16 | Warnings | M012 |
| CVS Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | de963dc3-8108-440f-e053-2995a90a906f | 2026-01-16 | Warnings | M012 |
| CVS SF Menthol Cough Drops | MENTHOL | CVS Pharmacy | e08f8ca3-b683-4964-e053-2a95a90afabb | 2026-01-16 | Warnings | M012 |
| CVS SF Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | e0cdeccf-c32f-318a-e053-2a95a90ac401 | 2026-01-16 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 66b3c094-809e-4d2c-bc15-46563de685cb | 7 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 66b3c094-809e-4d2c-bc15-46563de685cb | 7 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 66b3c094-809e-4d2c-bc15-46563de685cb | 7 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 66b3c094-809e-4d2c-bc15-46563de685cb | 7 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 66b3c094-809e-4d2c-bc15-46563de685cb | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54859-505-04 | 54859050504 | 118 mL in 1 BOTTLE (54859-505-04) | 118 ml | 2003-12-01 | 0000-00-00 | No | No | Current |
| 54859-505-16 | 54859050516 | 472 mL in 1 BOTTLE (54859-505-16) | 472 ml | 2003-12-01 | 0000-00-00 | No | No | Current |