Rompe Tos X Children
- Product NDC
- 69729-784
- 11-digit product format
- 697290784
- Labeler code
- 69729
- Product ID
- 69729-784_30b942ce-4452-9123-e063-6394a90ae60f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-18
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 250; 5; 13.33; 200 mg/10mL; mg/10mL; mg/10mL; mg/10mL
- 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
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69729-784-06 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69729-784-06 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69729-784-06 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69729-784-06 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Rompe Tos X Children
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 13.33 mg/10mL |
| GUAIFENESIN | 200 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1790651 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05cc932d-b412-0710-e063-6394a90a87f6 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-784-06 | 2025-12-23 | C162847 | 48780-1 | 2cef2736-61b6-d83d-e063-dadaa90ab31f | Rompe Tos X Children |
| 69729-784-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-61b6-d83d-e063-dadaa90ab31f | Rompe Tos X Children |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-784-06 | Rompe Tos X Children | 1 in 1 CARTON | SYRUP | 1 | 3 | |
| 69729-784-06 | Rompe Tos X Children | 177 mL in 1 BOTTLE, PLASTIC | SYRUP | 177 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Rompe Pecho DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | d108c712-bc36-41d7-9ccd-720496b5599e | 2025-10-14 | Warnings | M012 |
| Rompe Pechito DM for Kids | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 004d12e1-6e3d-84c8-e063-6394a90aa653 | 2025-10-14 | Warnings | M012 |
| VANACOF CP Allergy / Cough | CHLOPHEDIANOL HCL, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 0bdea30a-39da-6611-e063-6394a90aa4cf | 2025-10-14 | Warnings | M012 |
| VANACOF | CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | cf3886ab-62b3-497a-a587-18cbfbaf3634 | 2025-10-14 | Warnings | M012 |
| Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 42d4bafb-b630-487e-b63d-13ad37a59454 | 2025-10-14 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 410c19f7-213d-cd99-e063-6294a90af5a3 | 2025-10-13 | Warnings | M012 |
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | Rejoice International Corp. | 33d1fbf3-d33c-58b9-e063-6294a90ae098 | 2025-10-13 | Warnings | M012 |
| Nitetime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 2025-10-13 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | db81e32b-0cad-400b-8479-a3b51de92b12 | 2025-10-10 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852b77ae-a5ac-3ead-e053-2a91aa0a54bd | 2025-10-09 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 8503c956-42a5-7684-e053-2991aa0adb27 | 2025-10-09 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852ceea2-d6a1-6de2-e053-2a91aa0ad50d | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852d5f01-9289-5515-e053-2a91aa0acf32 | 2025-10-09 | Warnings | M012 |
| Giltuss Diabetic Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 85183b38-ce2a-0e0e-e053-2991aa0a336f | 2025-10-09 | Warnings | M012 |
| Giltuss MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 8518fd91-981e-de78-e053-2a91aa0afcb2 | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | M012 |
| Giltuss Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 85065cf3-386d-22d5-e053-2a91aa0a72da | 2025-10-09 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852c5a57-7ee4-3c5c-e053-2a91aa0a1433 | 2025-10-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution | PSN | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
| 1790651 | APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 05cc932d-b412-0710-e063-6394a90a87f6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69729-784-06 | 69729078406 | 1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC | 2023-09-18 | No | No | Current |