SAFETUSSIN Non Drowsy
- Product NDC
- 55505-220
- 11-digit product format
- 555050220
- Labeler code
- 55505
- Product ID
- 55505-220_cff65bfa-6667-4ecf-a98c-a93b50d2d161
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, and Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KRAMER LABORATORIES
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-01
- 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
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
- SAFETUSSIN Non Drowsy
- Brand name suffix
- Cough plus chest congestion
- 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 SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60311ca3-8544-417e-aa29-e9f65c6692ba | 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 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55505-220-33 | SAFETUSSIN Non DrowsyCough plus chest congestion | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 5 | |
| 55505-220-36 | SAFETUSSIN Non DrowsyCough plus chest congestion | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55505-220 | SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [KRAMER LABORATORIES] | 4 | Current NDC, 2 package rows | 20241208_60311ca3-8544-417e-aa29-e9f65c6692ba.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 Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe44d1ee-1e03-b74f-e053-6294a90a8bb4 | 2026-05-19 | Warnings | M012 |
| MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 325b41e1-f8d2-02ee-e063-6394a90aafff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 326f1fd3-73ab-e515-e063-6294a90ab222 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6c85df30-a601-4de6-9fd6-818265d799ff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2ee95e17-bd94-d717-e063-6294a90a2173 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Sinus Pressure Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2eeafd83-230c-af92-e063-6294a90a984e | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | M012 |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | M012 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Night | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | WALMART INC. | 312ae879-1124-40a4-b2ba-3f3070840021 | 2026-05-19 | Warnings | M012 |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | Warnings | M012 |
| Childrens Mucus Cough and Congestion Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8b5d391b-6c23-44c3-81d0-c08822bf6d01 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | b8132c81-5291-431a-ad3a-ec8a3eb21c19 | 2026-05-18 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55505-220-33 | 55505022033 | 118 mL in 1 BOTTLE, PLASTIC (55505-220-33) | 118 ml | 2025-07-01 | No | No | Current |
| 55505-220-36 | 55505022036 | 237 mL in 1 BOTTLE, PLASTIC (55505-220-36) | 237 ml | 2023-06-01 | No | No | Current |