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 |
|---|---|---|---|---|---|---|
| Family Wellness Oxymetazoline Sinus Severe | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 13237d31-c60a-49f8-9b96-4414cf766a08 | 2024-11-21 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5b55d1df-275b-40d8-bde3-fc43313b7eb3 | 2024-11-20 | Warnings | M012 |
| Halls Green Apple | MENTHOL | Mondelez Global LLC | 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2 | 2024-11-20 | Warnings | M012 |
| Halls Blueberry | MENTHOL | Mondelez Global LLC | 275a6935-ea44-486e-e063-6394a90ae19a | 2024-11-20 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 234bd567-4e3c-419f-a000-fdfc28cafc8b | 2024-11-20 | Warnings | M012 |
| NICE Assorted Cough Drops | MENTHOL | Leosons Overseas Corp | 96db0f37-41cc-1ebd-e053-2a95a90a3215 | 2024-11-19 | Warnings | M012 |
| Nice Cherry Cough Drops | MENTHOL | Leosons Overseas Corp | 98e52604-6e41-6408-e053-2995a90a6bc8 | 2024-11-19 | Warnings | M012 |
| NICE Citrus Cough Drops | MENTHOL | Leosons Overseas Corp | 96d9527d-9bf9-ce82-e053-2995a90aff0c | 2024-11-19 | Warnings | M012 |
| NICE Menthol Cough Drops | MENTHOL | Leosons Overseas Corp | 96d77897-475c-482c-e053-2995a90a2da4 | 2024-11-19 | Warnings | M012 |
| NICE Honey Lemon Cough Drops | MENTHOL | Leosons Overseas Corp | 96da2c9d-2d0d-6252-e053-2995a90ac338 | 2024-11-19 | Warnings | M012 |
| SanaTos Boost | DEXTROMETHORPHAN HBR | Pharmadel LLC | ae6a424f-f3f0-3f6c-e053-2995a90a972d | 2024-11-18 | Warnings | M012 |
| SanaTos Turbo Max Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | d56a071c-a747-5397-e053-2995a90aad8b | 2024-11-18 | Warnings | M012 |
| cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 404ef5f4-7b7b-4c08-b159-9175a91be132 | 2024-11-17 | Warnings | M012 |
| equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a24021a0-ef68-4bce-ba53-d262d1025cc0 | 2024-11-17 | Warnings | M012 |
| Cold and Cough DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | 4d5f93c1-7752-4948-ba58-c4385cfc24c8 | 2024-11-17 | Warnings | M012 |
| Good Sense Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 8a87104f-94a4-4585-afd5-d610eea32e39 | 2024-11-17 | Warnings | M012 |
| equate childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4 | 2024-11-17 | Warnings | M012 |
| foster and thrive childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 1eac715b-351c-4b47-8d1d-6e921813c1a4 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 2024-11-15 | Warnings | M012 |
| dg health day time severe cold and flu relief night time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | f721b393-9ad5-4fc6-a2c5-bd89e58caf16 | 2024-11-15 | 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 |