Sinus Congestion and Pain
- Product NDC
- 49035-527
- 11-digit product format
- 490350527
- Labeler code
- 49035
- Product ID
- 49035-527_dbfccbf6-2f75-4679-824d-f8cdfd7b7319
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin and Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-08-06
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 package | package | 49035-527 | 49035-527-42 | D | Discontinued by firm | 2026-10-21 |
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… |
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
- Sinus Congestion and Pain
- Brand name suffix
- Severe
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f51d1d52-39c2-4259-8b30-f9ac21edb265 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-527-08 | Sinus Congestion and PainSevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 19 | |
| 49035-527-08 | Sinus Congestion and PainSevere | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 19 | |
| 49035-527-42 | Sinus Congestion and PainSevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-527-08 | EA - Each | 49035-527 | 1bfb9649-66c8-411b-8590-9b64f2ccf3bb | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-527 | SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 18 | Current NDC, Legacy NDC, 3 package rows | 20250108_f51d1d52-39c2-4259-8b30-f9ac21edb265.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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 377248b6-d64d-8dff-e063-6394a90a43f6 | 2025-07-31 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 3771f778-7ac9-7108-e063-6394a90a1105 | 2025-07-31 | Warnings | M012 |
| tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca | 2025-07-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Wal-Mart Stores Inc | c38a2783-aed9-466d-8976-59d03a792c04 | 2025-07-30 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3b15d2ea-f784-275d-e063-6394a90a800c | 2025-07-29 | Warnings | M012 |
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | M012 |
| Childrens Robitussin Honey Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | b87f700e-3414-463c-80d4-c3dbca89a488 | 2025-07-29 | Warnings | M012 |
| Tussin DM | TUSSIN DM | Allegiant Health | 7a2f8d48-3123-4c37-b238-bd7cc4242bb7 | 2025-07-23 | Warnings | M012 |
| Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | 5fb2438b-8f2d-4af2-9981-42d278d26800 | 2025-07-23 | Warnings | M012 |
| DR. SANA COUGH AND CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | baca0580-4c30-4b94-89fa-a7cf06d4ff25 | 2025-07-22 | Warnings | M012 |
| Defensol D | ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI | Menper Distributors, Inc. | f466c660-69eb-4581-81ff-1499fa421d8b | 2025-07-22 | Warnings | M012 |
| Defensol D Blister Pack | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI | Menper Distributors, Inc. | 0dfcc977-6101-4536-e063-6294a90a7a48 | 2025-07-22 | Warnings | M012 |
| Broncofin | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Menper Distributors, Inc. | fdf67382-1692-485b-92f1-2cbb8be4fb70 | 2025-07-22 | Warnings | M012 |
| Defensol Adult Syrup | GUAIFENESIN, DEXTROMETHORPHAN HBR | Menper Distributors, Inc. | 62acff69-8c40-4a0e-8d56-be2cc14e3d45 | 2025-07-22 | Warnings | M012 |
| Cosedal Drops | DEXTROMETHORPHAN HBR, GUAIFENESIN | Menper Distributors, Inc. | 1241d249-ea3b-4d2b-87ed-835d6a2d286a | 2025-07-22 | Warnings | M012 |
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | M012 |
| Defensol-ito | DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE | Menper Distributors, Inc | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 2025-07-22 | Warnings | M012 |
| Bisolvine Children | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 896a5443-e3d2-4af7-9e27-f1c1899ce038 | 2025-07-22 | Warnings | M012 |
| Bisolvine Aloe-Miel | DEXTROMETHORPHAN, GUAIFENESIN | MENPER DISTRIBUTORS INC. | 34801c79-ce88-492f-808e-b639e8601607 | 2025-07-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 19 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 19 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 19 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-527-08 | 49035052708 | 2 BLISTER PACK in 1 CARTON (49035-527-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2005-08-06 | 0000-00-00 | No | No | Current |
| 49035-527-42 | 49035052742 | 12 TABLET, FILM COATED in 1 BLISTER PACK (49035-527-42) | 2005-08-06 | 0000-00-00 | No | No | Current |