Guaifenesin
- Product NDC
- 81033-102
- 11-digit product format
- 810330102
- Labeler code
- 81033
- Product ID
- 81033-102_316ac9e6-8d03-f55a-e063-6294a90a8540
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KESIN PHARMA CORPORATION
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-11-20
- Substance
- GUAIFENESIN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 100 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310604 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 365c01b7-a197-4876-85fc-42204f787e3a | Available on FDA.report |
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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81033-102-05 | Guaifenesin | 5 mL in 1 CUP, UNIT-DOSE | LIQUID | 5 | 7 | |
| 81033-102-10 | Guaifenesin | 10 mL in 1 CUP, UNIT-DOSE | LIQUID | 10 | 7 | |
| 81033-102-51 | Guaifenesin | 50 in 1 CARTON | LIQUID | 50 | 7 | |
| 81033-102-52 | Guaifenesin | 50 in 1 CARTON | LIQUID | 50 | 7 | |
| 81033-102-16 | Guaifenesin | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81033-102-05 | ML - Milliliter | 81033-102 | c04493a2-a5df-4be5-86e1-38cd698bbd63 | 1 | 2024-03-12 |
| 81033-102-10 | ML - Milliliter | 81033-102 | a990cc84-2678-4699-8dca-ec8808a024a4 | 1 | 2024-04-05 |
| 81033-102-16 | ML - Milliliter | 81033-102 | 7a1f8916-cb71-4e4c-a447-b4f532f27ea3 | 1 | 2025-06-13 |
| 81033-102-51 | ML - Milliliter | 81033-102 | 118824ef-231f-4404-85a9-9e31242703de | 1 | 2024-01-04 |
| 81033-102-52 | ML - Milliliter | 81033-102 | 0be6c67c-993a-4d6d-9ecc-515e876c5d39 | 1 | 2024-01-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81033-102 | GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION] | 7 | Current NDC, 4 package rows | 20250331_365c01b7-a197-4876-85fc-42204f787e3a.zip |
| 81033-102 | GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION] | 1 | Current NDC, 1 package rows | 20250406_31b8ad0a-3637-03db-e063-6394a90acdc3.zip |
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 |
|---|---|---|---|---|---|---|
| Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 14c56f3d-67fd-45ef-a16b-f27604722883 | 2026-05-12 | Warnings | M012 |
| ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | 51a4195b-8776-964c-e063-6294a90aa075 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe7eeb71-e219-4c84-ac06-98c3a40b14dc | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6f8241d7-0f30-40b3-926b-861c57079f1d | 2026-05-12 | Warnings | M012 |
| Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51a45db8-2bee-6fd0-e063-6394a90ab587 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 19da539e-7b57-41d7-aad5-fc89a6705e20 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 182222b5-a852-4dbe-b05f-a41d89806021 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8a790eeb-7d7d-4a94-9103-6ed09c04d596 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | dbdafbb4-f3c9-4042-b867-db4d06dc3d61 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 29571047-4c4b-44ca-8726-57c28308e8cf | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 75c6b92f-219f-4740-bb72-c02a927a21ff | 2026-05-12 | Warnings | M012 |
| Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | c746953f-4b7d-4e2a-9b85-96bd6901f517 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | cea08797-1d53-4434-be1a-144f2ded5f9d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 365c01b7-a197-4876-85fc-42204f787e3a | 7 |
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81033-102-05 | 81033010205 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | Historical | |||
| 81033-102-10 | 81033010210 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | Historical | |||
| 81033-102-16 | 81033010216 | 473 mL in 1 BOTTLE (81033-102-16) | 473 ml | 2025-04-01 | No | No | Current |
| 81033-102-51 | 81033010251 | 50 CUP, UNIT-DOSE in 1 CARTON (81033-102-51) / 5 mL in 1 CUP, UNIT-DOSE (81033-102-05) | 2023-11-20 | No | No | Current | |
| 81033-102-52 | 81033010252 | 50 CUP, UNIT-DOSE in 1 CARTON (81033-102-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-102-10) | 2023-11-20 | No | No | Current |