Severe Cold
- Product NDC
- 69842-505
- 11-digit product format
- 698420505
- Labeler code
- 69842
- Product ID
- 69842-505_16ba95c0-d108-4cd7-bb95-07cd8afc89b5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-12-27
- Marketing end
- 2026-12-27
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69842-505-16 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69842-505-16 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69842-505-16 | bd6a592717d7… | 303034d00443… |
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
- Severe Cold
- Brand name suffix
- Daytime
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1656815 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 258d27a9-fea6-4076-8dfa-77c7e982d250 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-505-16 | 2022-11-22 | C162847 | 48780-1 | d6a99b39-38b5-a426-e053-dadaa90af4c2 | Drug Facts |
| 69842-505-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-38b5-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-505-16 | Severe ColdDaytime | 1 in 1 BLISTER PACK | CAPSULE | 1 | 4 | |
| 69842-505-16 | Severe ColdDaytime | 16 in 1 CARTON | CAPSULE | 16 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69842-505 | SEVERE COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE [CVS PHARMACY] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240315_258d27a9-fea6-4076-8dfa-77c7e982d250.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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | WALGREENS CO. | bfc58cd5-9815-43af-895d-ec6cbd10937e | 2025-11-26 | Warnings | M012 |
| Walgreen Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREEN COMPANY | 40c038a3-91c7-4ed0-8210-65d58b82ca2b | 2025-11-26 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | WALGREENS CO | 724554ab-60b8-46c8-96a8-a98242604e3b | 2025-11-26 | Warnings | M012 |
| Walgreens Grape Flavor | CHILDREN COUGH AND CHEST CONGESTION | WALGREENS | 795cf1af-3847-46bc-b605-64a38e57cca2 | 2025-11-26 | Warnings | M012 |
| Walgreens | CHILDRENS STUFFY NOSE AND COLD | WALGREENS CO. | 7ac3de2d-1d10-49ec-a2da-da46977684ad | 2025-11-26 | Warnings | M012 |
| Childrens Chest Congestion Relief | GUAIFENESIN | WALGREENS COMPANY | c1382512-e6f3-4bdf-a9e6-4f68dd5ea553 | 2025-11-26 | Warnings | M012 |
| Dye Free Wal Sleep Z | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 96948973-09e3-4c05-8982-0494ebeaac4b | 2025-11-26 | Warnings | M012 |
| WALGREEN ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREEN COMPANY | 02ad9f98-07ad-4786-a1ab-169b870fec01 | 2025-11-26 | Warnings | M012 |
| Walgreen Cherry | GUAIFENESIN | WALGREEN COMPANY | 1f1cb4a5-1ebd-483c-bf82-16931da00e05 | 2025-11-26 | Warnings | M012 |
| Walgreen Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 2025-11-26 | Warnings | M012 |
| Walgreen Daytimel Kids Cold Cough plus Mucus | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 452159e0-1204-460c-981f-cace4e815c6f | 2025-11-26 | Warnings | M012 |
| Multi Symptom Wal Flu Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WALGREEN CO. | 9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb | 2025-11-25 | Warnings | M012 |
| WALGREEN Daytime Multi Symptom Flu Relief Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALGREENS CO. | c92a0f47-0b7c-4034-83d1-b7d2ed8022fc | 2025-11-25 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREENS CO. | 428081f5-b7eb-42da-963c-a587a44b2a79 | 2025-11-25 | Warnings | M012 |
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | M012 |
| Adult Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 586310f3-0014-4cfc-9d86-961b3fb7aa8c | 2025-11-25 | Warnings | M012 |
| childrens Allergy Dye Free Wal Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 4e64e040-1662-4dc9-b33f-3e119e0b3f7b | 2025-11-25 | Warnings | M012 |
| Walgreen | NASAL | WALGREENS CO | d38f8406-d7b9-472c-a472-58968bbdb993 | 2025-11-25 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 2025-11-25 | Warnings | M012 |
| Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | d13efbcd-1277-45d0-8389-1ba0337f7a24 | 2025-11-25 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 4 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69842-505-16 | 69842050516 | 16 BLISTER PACK in 1 CARTON (69842-505-16) / 1 CAPSULE in 1 BLISTER PACK | 16 blister pack | 2019-12-27 | 2026-12-27 | No | No | Current |