Cold Relief
- Product NDC
- 50844-529
- 11-digit product format
- 508440529
- Labeler code
- 50844
- Product ID
- 50844-529_50670273-19a0-4e1a-8699-39c271a663ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- L.N.K. International, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-07-21
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 product | product | 50844-529 | D | Discontinued by firm | 2026-10-15 | ||
| excluded product | product | 50844-529 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 50844-529 | 50844-529-02 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 50844-529 | 50844-529-08 | D | Discontinued by firm | 2026-10-15 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50844-529-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50844-529-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50844-529-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50844-529-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50844-529-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50844-529-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50844-529-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50844-529-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50844-529-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50844-529-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50844-529-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50844-529-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50844-529-08 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50844-529-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50844-529-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50844-529-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50844-529-08 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50844-529-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50844-529-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50844-529-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50844-529-08 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50844-529-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50844-529-08 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50844-529-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Relief
- Brand name suffix
- Multi-Symptom
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50844-529-09 | Cold ReliefMulti-Symptom | 1 in 1 CARTON | KIT | 1 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50844-529 | COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [L.N.K. INTERNATIONAL, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240825_2ed25f69-89ef-4c50-946a-7e7b9df1ca8a.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 |
|---|---|---|---|---|---|---|
| Cold Multi-Symptom Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b | 2026-04-16 | Warnings | M012 |
| Rompe Pecho Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 4f86985c-48f3-2148-e063-6394a90ae2f1 | 2026-04-15 | Warnings | M012 |
| Childrens Daytime Mucus | DEXTROMETHORPHAN HBR | Walgreens | 7a55b7e1-1054-421e-847e-5e4d90d1aebb | 2026-04-15 | Warnings | M012 |
| Childrens Nighttime Mucus | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | dc69f581-27c7-4030-bb18-39685c7691a1 | 2026-04-15 | Warnings | M012 |
| Pseudoephedrine HCl | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | da95c643-7122-4025-977f-42205080e56b | 2026-04-15 | Warnings | M012 |
| Daytime Nighttime Chewable | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | 9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6 | 2026-04-15 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4f7090f4-89c9-c3da-e063-6294a90a4716 | 2026-04-14 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN, PHENYLEPHRINE HCL | Walgreen Company | 2115f095-2d75-4e02-a6af-22dd693e0840 | 2026-04-14 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Lidl US LLC | 00f89eee-0edc-40dc-9297-8645afb91004 | 2026-04-14 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8647c136-a323-453a-8f57-e66938bbf639 | 2026-04-14 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5515148f-3e1d-4b03-89fa-40967d508292 | 2026-04-14 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c70e6506-6c5b-4d3f-ab18-a690840caabc | 2026-04-13 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Walgreen Company | 48387b95-8240-4d6e-842b-cc29cc18709c | 2026-04-13 | Warnings | M012 |
| Sinufrin Plus No Drip Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 4f06c732-1f9f-bfc6-e063-6394a90a53f5 | 2026-04-13 | Warnings | M012 |
| Severe Sinus Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8745d9d8-640d-4e3b-96fe-d25032c1e3ce | 2026-04-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 5a5c5f33-5b70-465d-a38b-6f518af09788 | 2026-04-13 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Publix Super Markets Inc | f2263e38-f686-45ed-bf85-b47f5e1aa982 | 2026-04-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | BETTER LIVING BRANDS, LLC | 46adbf94-5b93-ee64-e063-6294a90a1144 | 2026-04-11 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | 0c79357a-b79d-4952-8e6d-ef3d60dde2fa | 2026-04-10 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 88d27c25-a305-4398-9590-df10d2504b01 | 2026-04-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634560 | {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 / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 2634560 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | PSN | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1094538 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1094538 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 2634560 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | SY | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
| 1094538 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50844-529-02 | 50844052902 | 1 KIT in 1 PACKAGE, COMBINATION (50844-529-02) * 6 TABLET, FILM COATED in 1 BLISTER PACK * 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2005-07-21 | 0000-00-00 | No | No | Current |
| 50844-529-08 | 50844052908 | 1 KIT in 1 CARTON (50844-529-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2005-07-21 | 2022-11-24 | No | No | Current |
| 50844-529-09 | 50844052909 | 1 KIT in 1 CARTON (50844-529-09) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2005-07-21 | No | No | Current |