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 | 2026-10-15 |
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 | 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 |
|---|---|---|---|---|---|---|
| foster and thrive daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6 | 2026-06-16 | Warnings | M012 |
| Equate Severe Cold Cough and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | a35531d7-1a96-45cb-922f-61db085cde1f | 2026-06-16 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 5fe9f313-d6e7-41f5-abfc-e4c72b708961 | 2026-06-15 | Warnings | M012 |
| Pain Relief Sinus Congestion | ACETAMINOPHEN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 1d3d6397-0d92-4145-9a70-8bcc45bd0322 | 2026-06-15 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | d5d9334d-3db6-4f45-ab84-3e1ec5a752c6 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Geiss, Destin & Dunn Inc. | fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b | 2026-06-15 | Warnings | M012 |
| equate daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 2026-06-12 | Warnings | M012 |
| Equate Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 4173ecde-a2d7-4836-a6e9-fef2270d1b4e | 2026-06-12 | Warnings | M012 |
| PAIN RELIEVER PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | cf370a59-42d5-42fe-882f-09885c55f570 | 2026-06-11 | Warnings | M012 |
| Sudafed Sinus Congestion Plus Cold Severe Day | ACETAMINOPHEN, PSEUDOEPHEDRINE | Kenvue Brands LLC | 537e1a0d-820d-c3f7-e063-6294a90a56ea | 2026-06-10 | Warnings | M012 |
| Sudafed Sinus Congestion plus Cold Severe Day and Night | ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE | Kenvue Brands LLC | 5382dcad-0337-4440-e063-6394a90a706e | 2026-06-10 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 21cfa71c-7a8f-4100-a42e-9190260653d1 | 2026-06-09 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | WALGREENS | 47f1d92f-cb4b-1635-e063-6294a90a2c71 | 2026-06-09 | Warnings | M012 |
| HALLS Honey | MENTHOL | Mondelez Global LLC | 837f5ded-8efb-402b-a1bc-b5c142755660 | 2026-06-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 932b11b1-f4a0-417a-bfa1-05261a172155 | 2026-06-08 | Warnings | M012 |
| NO DRIP NASAL MIST | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 957efbcf-b6d3-4793-bb6e-27e99c9be905 | 2026-06-08 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 493caecb-e687-49ea-b7a1-2a5b9376896d | 2026-06-08 | Warnings | M012 |
| Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 4ad10fd7-c088-4356-9d34-a95cfe3a4133 | 2026-06-08 | Warnings | M012 |
| Theraflu Severe Congestion Relief Nasal Mist | OXYMETAZOLINE HCL | Haleon US Holdings LLC | 4ec42064-7390-4137-a93e-57343c3c76a7 | 2026-06-08 | 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 |