SUDAFED PE Pressure Plus Pain
- Product NDC
- 50580-547
- 11-digit product format
- 505800547
- Labeler code
- 50580
- Product ID
- 50580-547_217318f0-e484-c909-e063-6294a90a1bd1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen and phenylephrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-07-01
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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 | 50580-547 | 50580-547-73 | 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
- SUDAFED PE Pressure Plus Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1046378 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8538c291-9ce9-4866-b268-f4cbdb52f5bd | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50580-547-25 | 2024-02-06 | SUDAFED PE ® Pressure+Pain |
| 50580-547-73 | 2024-02-06 | SUDAFED PE ® Pressure+Pain |
| 50580-547-25 | 2024-01-30 | SUDAFED PE ® Pressure+Pain |
| 50580-547-73 | 2024-01-30 | SUDAFED PE ® Pressure+Pain |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-547-25 | SUDAFED PE Pressure Plus Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 15 | |
| 50580-547-25 | SUDAFED PE Pressure Plus Pain | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 15 | |
| 50580-547-73 | SUDAFED PE Pressure Plus Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 15 | |
| 50580-547-73 | SUDAFED PE Pressure Plus Pain | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-547-25 | EA - Each | 50580-547 | b3b25d88-3b75-466c-a7f0-b08a4e2194b7 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-547 | SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 15 | Current NDC, Legacy NDC, 4 package rows | 20241109_8538c291-9ce9-4866-b268-f4cbdb52f5bd.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 |
|---|---|---|---|---|---|---|
| CVS Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS PHARMACY | 3148f80f-8a0d-4b6c-85be-79085fc04444 | 2026-08-19 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | aa7164a7-f842-457d-abee-0740bb8c1c90 | 2026-08-19 | Warnings | M012 |
| CVS | CHILDRENS STUFFY NOSE AND COLD | CVS PHARMACY, INC | 6cff265d-94a3-4617-a366-fe970d97f05a | 2026-08-19 | Warnings | M012 |
| CVS Severe Congestion and Pain Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS | 5a8e4320-bae1-4831-b66b-9babfe8888d6 | 2026-08-19 | Warnings | M012 |
| CVS Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | CVS PHARMACY | 0ae0c244-e019-4b35-890c-8e15e3d3f7ce | 2026-08-19 | Warnings | M012 |
| CVS Severe Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | e32881f5-2bb5-4756-aa86-a09473ab590b | 2026-08-19 | Warnings | M012 |
| Good Sense Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | L. Perrigo Company | d2541ef0-a73c-43aa-91ff-fdbce2748c4f | 2026-08-18 | Warnings | M012 |
| CVS Severe Nasal Congestion Relief Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 5a7e42ee-810c-4bc1-9d8d-fac8e849e126 | 2026-08-18 | Warnings | M012 |
| DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8dd039b4-209a-484a-b15e-741d55087a93 | 2026-08-18 | Warnings | M012 |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | M012 |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | M012 |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | M012 |
| Mucinex Fast-Max DM Max Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | da1f1ef9-a974-4998-8e1d-c1d999596943 | 2026-08-18 | Warnings | M012 |
| CVS Health Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 89168715-71b1-424e-8dae-fcfa90bc85bf | 2026-08-18 | Warnings | M012 |
| CVS Health Sinus | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | c7840511-3a4f-4547-ae90-19b085a5874e | 2026-08-17 | Warnings | M012 |
| CVS Health | NASAL OXYMETAZOLINE HCL | CVS Pharmacy,Inc. | 56f08e70-bf16-4933-97bc-177bc190d12a | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | ALLERGY NASAL | CVS PHARMACY,INC. | 3e76ffac-07a7-4b6a-bc4c-9cabb653e064 | 2026-08-17 | Warnings | M012 |
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | M012 |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | M012 |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046378 | acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
| 1046378 | acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
| 1046378 | APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-547-25 | 50580054725 | 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-07-01 | 0000-00-00 | No | No | Current |
| 50580-547-73 | 50580054773 | 2 BLISTER PACK in 1 CARTON (50580-547-73) > 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2018-12-21 | 0000-00-00 | No | No | Current |