DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Product NDC
- 69729-020
- 11-digit product format
- 697290020
- Labeler code
- 69729
- Product ID
- 69729-020_5d203e0a-2498-6041-e063-6294a90a885b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-02-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 300 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
- 2027-12-31
- 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 69729-020 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69729-020 | 69729-020-04 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
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
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| GUAIFENESIN | 300 mg/5mL |
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 |
| 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#
| Effective | Related label |
|---|---|
| 2024-04-02 | Histiacil NF Pentrexicilina NF Brosolvan |
| 2024-04-02 | Histiacil NF Pentrexicilina NF Brosolvan |
| 2024-01-30 | Histiacil NF Pentrexicilina NF Brosolvan |
| 2024-01-30 | Histiacil NF Pentrexicilina NF Brosolvan |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-020-04 | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | 118 mL in 1 BOTTLE | SYRUP | 118 | 7 |
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 |
|---|---|---|---|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2 | 2026-08-10 | Warnings | M012 |
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a9f01760-e335-4410-a9b8-8edce2841270 | 2026-08-10 | Warnings | M012 |
| Guaifed | GUAIFENESIN | Aldama Pharmaceuticals, Inc | 38f37272-2084-a33b-e063-6294a90ac150 | 2026-08-10 | Warnings | M012 |
| Chlorpheniramine Maleate | CHLORPHENIRAMINE MALEATE | PD-Rx Pharmaceuticals, Inc. | 7a3452a2-930f-48b1-8c59-dbceb10b9c78 | 2026-08-10 | Warnings | M012 |
| Guaifed DM | DEXTROMETHORPHAN, GUAIFENESIN | Aldama Pharmaceuticals, Inc | 396bf716-0f61-9563-e063-6394a90a171b | 2026-08-10 | Warnings | M012 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | eff114fe-fb15-48dd-b673-4d4d66406e69 | 2026-08-10 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 651b03a3-b85e-4028-a9f2-472bec16c8f4 | 2026-08-10 | Warnings | M012 |
| NASAL | PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 02a89765-2a75-470a-9fd6-8cce71dc19e9 | 2026-08-10 | Warnings | M012 |
| WINCO Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WINCO FOODS, LLC | f34bfb71-2c81-44d0-a2a0-4d320c43c217 | 2026-08-07 | Warnings | M012 |
| DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 11cac20e-9bb6-4e2d-8efd-4451f055c7b4 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | 1d02b32a-e88d-4c70-b66d-7bdc22c25a43 | 2026-08-07 | Warnings | M012 |
| foster and thrive daytime cold and flu relief nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | c1ecc56b-8052-4b0a-900a-dc93a24771bd | 2026-08-07 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | bbf7d296-fa3d-43e5-984c-e9d2881a074d | 2026-08-07 | Warnings | M012 |
| Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | WinCo Foods, LLC | 790d534a-0f40-495b-a815-67851ac3d20d | 2026-08-07 | Warnings | M012 |
| Extra Moisturizing Nasal Pump Mist Anti Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | 46ebd262-c6a4-43ea-a7f6-506561bb3de4 | 2026-08-07 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | WINCO FOODS, LLC | e6afa830-6ce2-4abc-b5c9-3f5f156444df | 2026-08-07 | Warnings | M012 |
| Sinus PE Pressure plus Pain MAXIMUM STRENGTH | ACETAMINOPHEN, PHENYLEPHRINE HCL | CVS Pharmacy | a3b073b4-494c-4531-b08e-475c86ba321d | 2026-08-07 | Warnings | M012 |
| Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WinCo Foods, LLC | dc56197c-c108-4b35-b791-dde5c3384ddd | 2026-08-07 | Warnings | M012 |
| Sinus Severe Non Drowsy, Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 84c30ec9-a7b5-4d2f-95b2-d6fb895945de | 2026-08-07 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 887cabe5-46d0-4f4e-8f5a-2cfdbc157b58 | 2026-08-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1117394 | dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral Solution | PSN | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
| 1117394 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution | SCD | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
| 1117394 | dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral Solution | SY | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69729-020-04 | 69729002004 | 118 mL in 1 BOTTLE (69729-020-04) | 118 ml | 2021-02-01 | 0000-00-00 | No | No | Current |