Daytime Non Drows Cold and Flu and Nighttime Cold and
- Product NDC
- 68210-5008
- Requested package NDC
- 68210-5008-4
- 11-digit product format
- 682105008
- Labeler code
- 68210
- Product ID
- 68210-5008_efa9cdd7-9a3d-341a-e053-2995a90a0fc0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
- Dosage form
- KIT
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-10-19
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68210-5008 | 68210-5008-4 | I | Inactivated by FDA | 2026-10-16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-5008-4 | Daytime Non Drows Cold and Flu and Nighttime Cold and | 1 in 1 CARTON | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-5008 | DAYTIME NON DROWS COLD AND FLU AND NIGHTTIME COLD AND (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [SPIRIT PHARMACEUTICALS LLC] | 4 | Legacy NDC, 1 package rows | 20241213_c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1426334 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1426334 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1426334 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | c7b1b4f3-9f4f-4a8c-88f8-ce7a8c1d2ec0 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68210-5008-4 | 68210500804 | 1 KIT in 1 CARTON (68210-5008-4) * 4 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2022-12-12 | 0000-00-00 | No | No | Current |