Stona-S
- Product NDC
- 49873-113
- 11-digit product format
- 498730113
- Labeler code
- 49873
- Product ID
- 49873-113_0bb87850-ad34-ce89-e063-6294a90a421d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sato Pharmaceutical Co., Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2004-09-27
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Listing certified through
- 2026-12-31
- 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 |
|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 49873-113-90 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 49873-113-90 | 5b2001dcd8f5… | 54b53d4dc9e4… |
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
- Stona-S
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 162.5 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1242747 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49873-113-01 | Stona-S | 1 in 1 CARTON | CAPSULE | 1 | 8 | |
| 49873-113-01 | Stona-S | 24 in 1 BOTTLE | CAPSULE | 24 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49873-113 | STONA-S (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE [SATO PHARMACEUTICAL CO., LTD.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231205_2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1.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 |
|---|---|---|---|---|---|---|
| topcare childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | 40a6a7e3-6ec9-4005-9406-9d5b044b3c21 | 2025-06-16 | Warnings | M012 |
| Daytime Nighttime Sinus Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Target Corporation | 23f50b88-52c3-2029-e063-6394a90ac73e | 2025-06-14 | Warnings | M012 |
| Cough Drops Dollar General Berries Flavor 25ct | PECTIN | Dollar General Corporation | c53c19a9-5984-4b08-ae46-a53dc8bb7d74 | 2025-06-13 | Warnings | M012 |
| Cough Drops Dollar General Strawberry Flavor 25ct | PECTIN | Dollar General Corporation | d82034ca-b7fd-48c8-ab4a-8e1e56418324 | 2025-06-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Belleview Biosciences | 1db57d86-39f0-f8ca-e063-6394a90a6397 | 2025-06-12 | Warnings | M012 |
| TARGET Cold and Cough and Nighttime Value Pack | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL, | TARGET CORPORATION | ce536313-7265-405c-88b7-f45e62781da5 | 2025-06-11 | Warnings | M012 |
| Capron Max | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3756812b-f128-8946-e063-6294a90a59ba | 2025-06-11 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 60311ca3-8544-417e-aa29-e9f65c6692ba | 2025-06-11 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65d2815-6932-123c-e053-2a95a90a2cf9 | 2025-06-10 | Warnings | M012 |
| Cold Head Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | 0cc66c6c-db26-4bb2-a97d-c4106210d70c | 2025-06-10 | Warnings | M012 |
| Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 75a9c736-bc7e-4b7f-84ea-9474a37508ec | 2025-06-10 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | 8877bb8d-479f-4968-8033-5c269d449a46 | 2025-06-10 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 2025-06-09 | Warnings | M012 |
| Equate Kids Daytime Dex Cough Gels | DEXTROMETHORPHAN | Walmart | 37269cd6-1528-9879-e063-6394a90a2b54 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | bdc35570-c8df-4797-a13e-7f2479ec42b7 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | f5764925-c586-40e4-8252-24d92389af01 | 2025-06-09 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 7fa8e4ad-95cb-4905-90db-d53b3bc87c41 | 2025-06-09 | Warnings | M012 |
| Vaporizing Steam Liquid | MEDICATED COUGH SUPPRESSANT | NeilMed Pharmaceuticals Inc. | 36cf6218-adb8-9d8b-e063-6394a90a49a0 | 2025-06-05 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 7e2fb43c-a7f1-4c1d-a700-7c6510999c03 | 2025-06-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1242747 | acetaminophen 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 8 |
| 1242747 | acetaminophen 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 8 |
| 1242747 | APAP 162.5 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49873-113-01 | 49873011301 | 1 BOTTLE in 1 CARTON (49873-113-01) / 24 CAPSULE in 1 BOTTLE | 1 bottle | 2014-04-25 | 0000-00-00 | No | No | Current |