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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 2cbf27b6-217c-46d8-89c9-e46f3668f002 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d86d53cd-75ce-4c40-83cb-ada9b77a76f6 | 2026-07-17 | Warnings | M012 |
| LEADER Multi Symptom Flu Relief Daytime Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 2212cf9e-6944-4922-b5b5-1373cf10b2e1 | 2026-07-16 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | CVS PHARMACY | 06756130-1608-4ae6-9772-95a4549853a1 | 2026-07-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Old East Main Co. | 7855033e-6a12-4cd8-b0a2-c5d69018d117 | 2026-07-16 | Warnings, Adverse reactions | M012 |
| Oxymetazoline Hydrochloride 12-Hour | OXYMETAZOLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 34a79f8b-32b7-48db-a895-c942cc795292 | 2026-07-16 | Warnings | M012 |
| LoHist D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | 93c9ad4f-3376-48c2-8276-0375663acd01 | 2026-07-16 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 522e1e7f-98ed-c475-e063-6294a90a622c | 2026-07-16 | Warnings | M012 |
| LEADER MS Flu Relief Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d | 2026-07-16 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 1bf4cd96-5800-434d-a0dc-e84c759ebb33 | 2026-07-16 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | Walgreens | 2ace231a-94c4-479d-bb26-454bd07b207b | 2026-07-16 | Warnings | M012 |
| LEADER No Drip | ALLERGY SINUS NASAL MIST | CARDINAL HEALTH 110, LLC. DBA LEADER | e7b2c1c1-6250-4af3-b131-22aced2b23d5 | 2026-07-16 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amerisource Bergen | 639a59b7-ccff-485e-a232-38b680827229 | 2026-07-16 | Warnings | M012 |
| Equate Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | 30470a01-4d42-44c6-a017-d68bb74cdef7 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93fe6d-ee21-e323-e063-6394a90a61bf | 2026-07-15 | Warnings | M012 |
| Pentrexcilina Daytime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b7b3c15a-bb28-5c25-e053-2a95a90ad3b1 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93c815-63c7-bfe0-e063-6394a90ab4a5 | 2026-07-15 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 5fa848ef-35ee-4e05-8ff2-781d034cf6ac | 2026-07-14 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | 0fad61d8-4393-47ec-9ff6-7df5be761f5b | 2026-07-14 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Rite Aid Corporation | 211c4273-3b2c-4169-b9c6-7a87903e77cd | 2026-07-13 | 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 |