TopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu Relief
- Product NDC
- 36800-562
- Requested package NDC
- 36800-562-08
- 11-digit product format
- 368000562
- Labeler code
- 36800
- Product ID
- 36800-562_19826132-4b2e-4c61-87f1-50ccb4d8173f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen ,Dextromethorphan Hydrobromide and Phenylephrine HCl ,Acetaminophen,Dextromethorphan HBR,Doxylamine succinate
- Dosage form
- KIT
- Labeler
- TopCare Health
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-03-06
- 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 | 36800-562 | 36800-562-08 | I | Inactivated by FDA | 2026-10-05 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-562-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2d57-111a-e063-dadaa90a10e2 | TopCare health ™ Day and Night Combination Pack Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Nighttime Cold and Flu Relief Single Serve Cups |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-562-08 | TopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu ReliefDay and Night Combo Pack | 1 in 1 KIT | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-562 | TOPCARE HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF DAY AND NIGHT COMBO PACK (ACETAMINOPHEN ,DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HCL ,ACETAMINOPHEN,DEXTROMETHORPHAN HBR,DOXYLAMINE SUCCINATE) KIT [TOPCARE HEALTH] | 4 | Legacy NDC, 1 package rows | 20221201_90358b3c-63c9-4aef-a241-9a6e588535d5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2119242 | {1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } Pack | GPCK | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 2119242 | {1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } Pack | PSN | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1805288 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution | PSN | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1805288 | acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution | SCD | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 2119242 | {1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } Pack | SY | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution | SY | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1805288 | acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Granules for Oral Solution | SY | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1659967 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
| 1805288 | APAP 650 MG / Dextromethorphan Hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution | SY | 90358b3c-63c9-4aef-a241-9a6e588535d5 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-562-08 | 36800056208 | 1 KIT in 1 KIT (36800-562-08) * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP | 1 kit | 2019-03-06 | 0000-00-00 | No | No | Current |