COLD AND FLU SEVERE
- Product NDC
- 53943-186
- 11-digit product format
- 539430186
- Labeler code
- 53943
- Product ID
- 53943-186_24aedb24-6067-5e7c-e063-6394a90aaba0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- KIT
- Labeler
- DISCOUNT DRUG MART
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-05-01
- 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
- COLD AND FLU SEVERE
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-186-01 | COLD AND FLU SEVERE | 1 in 1 CARTON | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53943-186 | COLD AND FLU SEVERE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [DISCOUNT DRUG MART] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241208_ddeb8978-84b6-4a19-b25e-99d1c29e58d9.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 Severe Congestion and Cough | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1991d5ee-fc90-4070-8965-cd6f4abc45cf | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba2cc08-acad-79a8-e063-6394a90af17f | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | a3523aa3-9ed1-472d-9986-438440d0a3eb | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ed3c844-0532-40d9-beba-738d196de34d | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 1e243dbe-138f-4346-ba22-ceea01e97052 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 128f3442-9802-4303-80be-aead09237936 | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 33f0d9bb-c67d-92ba-e063-6294a90a9943 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2c01962d-74e3-4dfa-b7cb-a91a687711d5 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | f5365c6d-9296-41a5-953a-d1008954e67f | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8905706b-b9da-4520-8cf2-87d7c125edf3 | 2026-05-13 | Warnings | M012 |
| MUCINEX Rapid Clear Day Night and Clear and Cool Nasal | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 37dcb0ed-df56-1bec-e063-6394a90a695e | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 373e0d75-8def-4b98-e063-6394a90a5e47 | 2026-05-13 | Warnings | M012 |
| MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5a397466-8721-4060-a178-5ebfd7069cc9 | 2026-05-13 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | M012 |
| Cepacol Extra Strength Sore Throat and Cough | BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c0cc32db-90f0-4106-8538-89821083ece1 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 316b5569-b66f-f30c-e063-6394a90ae147 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9467ca2-df75-4fa1-92b3-d2101eb54a77 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 12420092-3ef6-464b-9106-2d56cd6ef200 | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634819 | {1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | PSN | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | SY | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53943-186-01 | 53943018601 | 1 KIT in 1 CARTON (53943-186-01) * 8 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK | 1 kit | 2019-05-01 | 0000-00-00 | No | No | Current |